[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aspargo Labs, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":240},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,40,63,83,100,115,131,148,174,193,215],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100615268","phase-2-effect-of-moderate-alcohol-on-absorption-and-onset-of-hezkue-sildenafil-suspension-100615268",false,"NCT07290400","Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension","Phase 2 Crossover Study Assessing the Effect of Moderate Alcohol Intake on the Absorption and Onset of Action of Hezkue® Sildenafil Oral Suspension","Inclusion Criteria:\n\n* Male adults 21 to 65 years of age, inclusive\n* Documented history of erectile dysfunction for at least 6 months, as determined by the investigator\n* In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable\n* Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator\n* Able, in the investigator's judgment, to safely consume moderate amounts of alcohol as defined in the protocol\n* Willing to abstain from alcohol outside of protocol-specified intake during the study\n* Able to understand and provide written informed consent before any study-specific procedures are performed\n* Willing and able to comply with all study procedures, including dosing, washout periods, pharmacokinetic sampling, onset assessments, and safety monitoring\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation\n* Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period\n* Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension\n* Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator\n* Significant hepatic, renal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that could increase risk or interfere with study assessments\n* History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol\n* History of alcohol use disorder, binge drinking, or other substance use disorder, as determined by the investigator\n* Positive urine drug screen or positive alcohol test at screening or admission (outside protocol-specified alcohol administration)\n* Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before first dosing unless approved by the investigator\n* Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV\n* Participation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives, whichever is longer\n* Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before first dosing\n* Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable or interfere with study conduct or interpretation","MALE","18 Years","70 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.",[27],"Erectile Dysfunction","NOT_YET_RECRUITING","2025-12-16",{"date":31,"type":32},"2025-12-18","ACTUAL",{"date":34,"type":21},"2026-04-15",{"date":36,"type":21},"2026-06-28",{"name":38,"class":39},"Aspargo Labs, Inc","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100616214","phase-1-pk-and-onset-of-hezkue-oral-sildenafil-suspension-after-alcohol-consumption-100616214","NCT07302698","PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption","Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults","Inclusion Criteria:\n\n* Male or female adults 21 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.\n\nAble to safely consume moderate amounts of alcohol as judged by the investigator (for example, no history of alcohol intolerance, alcohol use disorder, or alcohol-related medical complications).\n\nBlood pressure and heart rate within normal or non-clinically significant ranges at screening and baseline, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.\n\nAble to understand and provide written informed consent before any study-specific procedures are performed.\n\nWilling and able to comply with all study requirements, including alcohol restrictions, fasting, dosing schedules, and pharmacokinetic and onset assessments.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.\n\nResting systolic blood pressure or diastolic blood pressure, or heart rate, outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator.\n\nKnown hypersensitivity or contraindication to sildenafil, other phosphodiesterase type 5 (PDE5) inhibitors, alcohol, or any component of the study formulations.\n\nCurrent or recent use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (for example, riociguat).\n\nHistory of significant hepatic, renal, gastrointestinal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that, in the investigator's opinion, could interfere with study participation or data interpretation.\n\nHistory of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol.\n\nHistory of alcohol use disorder, binge drinking patterns, or other substance use disorder, as determined by the investigator.\n\nPositive urine drug screen or positive alcohol test at screening (outside scheduled alcohol administration for the study) or at admission.\n\nUse of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nParticipation in another clinical study or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before the first study dose.\n\nDonation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with compliance or study assessments.",true,{"count":49,"type":21},24,[51],"PHASE1","This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.",[54],"Healthy Volunteers","2025-12-11",{"date":57,"type":32},"2025-12-24",{"date":59,"type":21},"2026-03-15",{"date":61,"type":21},"2026-05-28",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":47,"sex":70,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":82,"locationsCount":4},"100616008","phase-1-pk-and-relative-bioavailability-of-novel-liquid-metformin-vs-tablets-100616008","NCT07300020","PK and Relative Bioavailability of Novel Liquid Metformin vs Tablets","Single-Dose Pharmacokinetics and Relative Bioavailability of a Novel Liquid Metformin Formulation (100 mg\u002FmL and 250 mg\u002FmL) Compared With Immediate-Release Metformin Tablets in Adult Subjects","Inclusion Criteria:\n\n* Male or female adults 18 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement periods, as determined by the investigator.\n\nAble to understand and provide written informed consent before any study-specific procedures are performed.\n\nWilling and able to comply with all study requirements, including fasting requirements, visit schedules, and pharmacokinetic blood sampling.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to metformin or any component of the study formulations.\n\nHistory or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the opinion of the investigator, could interfere with study participation or interpretation of results.\n\nEstimated glomerular filtration rate (eGFR) less than 90 mL\u002Fmin\u002F1.73 m², or any clinically significant abnormality in clinical laboratory tests.\n\nHistory of lactic acidosis.\n\nUse of any prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug screen or positive alcohol breath test at screening or at admission to the clinical unit.\n\nParticipation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before the first study dose.\n\nDonation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable methods of contraception.\n\nAny condition or circumstance that, in the opinion of the investigator, would make the subject unsuitable for the study.","ALL","55 Years",{"count":49,"type":21},[51],"This is an open-label, randomized, three-period crossover study evaluating the single-dose pharmacokinetics and relative bioavailability of a novel liquid metformin formulation at concentrations of 100 mg\u002FmL and 250 mg\u002FmL compared with immediate-release metformin tablets in healthy adult subjects. All participants will receive each formulation in randomized sequence with washout periods between treatments. Serial blood samples will be collected to characterize metformin pharmacokinetic parameters, and safety and tolerability will be assessed throughout the study.",[76],"Healthy Volunteer","2025-12-10",{"date":79,"type":32},"2025-12-23",{"date":34,"type":21},{"date":36,"type":21},{"name":38,"class":39},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":47,"sex":70,"minAge":17,"maxAge":71,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100616011","phase-1-short-term-glycemic-effects-of-liquid-metformin-vs-standard-tablets-100616011","NCT07300059","Short-Term Glycemic Effects of Liquid Metformin vs Standard Tablets","Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults","Inclusion Criteria:\n\n\\- Male or female adults 18 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.\n\nFasting blood glucose within the normal reference range at screening.\n\nNon-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during each study confinement period.\n\nAble to understand and provide written informed consent before participation.\n\nWilling and able to comply with all study procedures, including fasting requirements, glycemic assessments, and timed blood draws.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.\n\nHistory or presence of any clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric condition that, in the investigator's judgment, could interfere with study participation or data interpretation.\n\nFasting blood glucose outside the normal reference range at screening, or any history of hypoglycemia or glucose regulation disorders.\n\nEstimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m² or any clinically significant abnormal clinical laboratory results.\n\nHistory of lactic acidosis.\n\nUse of prescription medications, over-the-counter medications, vitamins, herbal supplements, or dietary supplements within 14 days before first study dosing, unless approved by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug screen or positive alcohol breath test at screening or admission.\n\nParticipation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first study dose.\n\nDonation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition that, in the opinion of the investigator, would make the participant unsuitable for the study.",{"count":49,"type":21},[51],"This is an open-label, randomized study evaluating the short-term glycemic effects of two concentrations of liquid metformin formulations (100 mg\u002FmL and 250 mg\u002FmL) compared with standard immediate-release metformin tablets in healthy adult subjects. Participants will receive single or short-term doses of study treatments in a randomized sequence. Blood glucose measurements and other glycemic indicators will be collected to assess short-term pharmacodynamic effects. Safety and tolerability will also be monitored.",[54],{"date":79,"type":32},{"date":96,"type":21},"2026-07-15",{"date":98,"type":21},"2026-08-28",{"name":38,"class":39},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":47,"sex":70,"minAge":17,"maxAge":71,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":114,"locationsCount":4},"100616007","phase-1-pk-and-relative-bioavailability-of-liquid-metformin-vs-tablets-in-healthy-adults-100616007","NCT07300007","PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults","An Open-Label, Randomized, Crossover Study to Characterize the Pharmacokinetics and Relative Bioavailability of Liquid Metformin at 100 mg\u002FmL and 250 mg\u002FmL Compared With Standard Metformin Tablets","Inclusion Criteria:\n\n* Male or female adults 18 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy with no clinically significant findings on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests, in the opinion of the investigator.\n\nNon-smokers or light smokers (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement.\n\nAble to understand and provide written informed consent before any study procedures are conducted.\n\nWilling and able to comply with all study requirements, including fasting restrictions and visit schedules.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.\n\nHistory or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders that could affect study participation or data interpretation.\n\nEstimated glomerular filtration rate (eGFR) less than 90 mL per minute per 1.73 square meters, or any clinically significant abnormal laboratory findings.\n\nHistory of lactic acidosis.\n\nUse of prescription medications, over-the-counter medications, herbal supplements, or dietary supplements within 14 days before first dosing, unless approved by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug test or positive alcohol breath test at screening or admission.\n\nParticipation in another clinical trial or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before first study dose.\n\nBlood donation of more than 450 mL or significant blood loss within 8 weeks before first dosing.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition that, in the opinion of the investigator, would make the participant unsuitable for the study.",{"count":49,"type":21},[51],"The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg\u002FmL and 250 mg\u002FmL)",[76],{"date":79,"type":32},{"date":59,"type":21},{"date":61,"type":21},{"name":38,"class":39},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":47,"sex":70,"minAge":17,"maxAge":71,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":130,"locationsCount":4},"100616010","phase-1-tolerability-study-of-liquid-metformin-100-and-250-mgml-vs-ir-tablets-100616010","NCT07300046","Tolerability Study of Liquid Metformin (100 and 250 mg\u002FmL) vs IR Tablets","A Randomized Study to Assess the Tolerability Profile of Two Concentrations of Liquid Metformin (100 mg\u002FmL and 250 mg\u002FmL) Compared With Standard Metformin Tablets","Inclusion Criteria:\n\n* Male or female adults 18 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.\n\nAble to provide written informed consent before any study-specific procedures are conducted.\n\nWilling and able to comply with all study requirements, including fasting, dosing restrictions, and safety\u002Ftolerability assessments.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.\n\nHistory or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the investigator's opinion, could interfere with participation or data interpretation.\n\nEstimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m², or any clinically significant abnormal clinical laboratory findings.\n\nPrior history of lactic acidosis.\n\nCurrent or recent (within 14 days before first dose) use of prescription drugs, over-the-counter medications, herbal products, or dietary supplements, unless approved by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug screen or positive alcohol breath test at screening or at check-in.\n\nParticipation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before first study dose.\n\nDonation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition or finding that, in the opinion of the investigator, would make the subject unsuitable for the study.",{"count":49,"type":21},[51],"This is an open-label, randomized study evaluating the tolerability of two concentrations of liquid metformin formulations (100 mg\u002FmL and 250 mg\u002FmL) compared with standard immediate-release metformin tablets in healthy adult subjects. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.",[54],{"date":79,"type":32},{"date":128,"type":21},"2026-06-15",{"date":98,"type":21},{"name":38,"class":39},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":47,"sex":70,"minAge":17,"maxAge":71,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100616009","phase-1-bioequivalence-study-of-liquid-metformin-100-and-250-mgml-vs-ir-tablets-100616009","NCT07300033","Bioequivalence Study of Liquid Metformin (100 and 250 mg\u002FmL) vs IR Tablets","Bioequivalence of Liquid Metformin (100 mg\u002FmL and 250 mg\u002FmL) and Immediate-Release Metformin Tablets: A Randomized, Crossover Study in Adult Subjects","Inclusion Criteria:\n\n* Male or female adults 18 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead ECG, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement periods.\n\nAble to understand and provide written informed consent prior to participation in the study.\n\nWilling and able to comply with all study requirements, including fasting requirements and pharmacokinetic blood sampling.\n\nFemales of childbearing potential must use an acceptable method of contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to metformin or any component of the study formulations.\n\nHistory or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorder that, in the opinion of the investigator, could interfere with study participation or interpretation of results.\n\nEstimated glomerular filtration rate (eGFR) less than 90 mL\u002Fmin\u002F1.73 m², or any clinically significant abnormal clinical laboratory findings.\n\nHistory of lactic acidosis.\n\nUse of prescription or over-the-counter medications, herbal supplements, or dietary supplements within 14 days before the first study dose, unless approved by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug screen or positive alcohol breath test at screening or admission.\n\nParticipation in another clinical trial or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first study dose.\n\nDonation of 450 mL or more of blood, or significant blood loss, within 8 weeks before first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition or situation that, in the opinion of the investigator, would make the participant unsuitable for the study.",{"count":49,"type":21},[51],"This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg\u002FmL and 250 mg\u002FmL compared with immediate-release metformin tablets in healthy adult subjects. Each participant will receive both treatments in randomized sequence with an adequate washout interval between periods. Serial blood samples will be collected to assess metformin pharmacokinetics, and safety will be monitored throughout the study.",[76],{"date":79,"type":32},{"date":144,"type":21},"2026-05-15",{"date":146,"type":21},"2026-07-28",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100601967","phase-1-hezkue-hezkue-turbo-and-commercial-sildenafil-products-in-fed-healthy-male-subject-100601967","NCT07117383","Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject","A Phase 1 Pharmacokinetic Study Comparing Hezkue® (ASP-001), Hezkue Turbo® (ASP-001.1), and Select Commercially Available Sildenafil Products Under Fed Conditions in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.\n* Participant must be a healthy male, aged 18 to 70 years (inclusive) at the time of dosing.\n* Participant must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.\n* Participant must have a creatinine clearance (CrCl) value greater than 80 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n* Participant must agree to practice an acceptable method of contraception throughout the clinical trial, as outlined in the protocol.\n\nExclusion Criteria:\n\n* Unwilling or unable to comply with study procedures.\n* Use of any investigational drug (except Hezkue\u002FHezkue Turbo) within 30 days prior to dosing.\n* History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, infectious disease, or diabetes mellitus.\n* Clinically significant abnormal lab results, vital signs, or ECGs.\n* Any hepatic impairment or abnormal liver function tests.\n* Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.\n* Clinically significant illness within 28 days prior to dosing.\n* Known hypersensitivity to sildenafil, tadalafil, vardenafil, or any component of the investigational product (e.g., peppermint oil).\n* History of significant food or drug allergies.\n* History of drug abuse within the past year or positive drug screen at screening.\n* Regular alcohol consumption exceeding 15 units per week.\n* Use of CYP450 enzyme inhibitors within 14 days prior to dosing.\n* Use of CYP450 enzyme inducers or St. John's Wort within 28 days prior to dosing.\n* Blood donation or significant blood loss within 3 months before screening.\n* Plasma donation within 14 days prior to first dose.\n* Inadequate venous access for repeated blood sampling.\n* Difficulty fasting or inability to consume standardized meals.\n* Intolerance to fatty foods or inability to consume a high-fat, high-calorie breakfast.\n* Difficulty swallowing.\n* Regular use of tobacco or nicotine products within 4 weeks prior to screening.\n* Major surgery within 3 months or minor surgery within 1 month before screening.\n* Considered unsuitable for study participation by the Investigator.\n* Institutionalized status.\n* Use of hormone replacement therapy within 6 months prior to dosing.\n* Consumption of Seville oranges, grapefruit, or pomelo within 7 days prior to dosing.\n* Consumption of caffeine, xanthine-containing products, or poppy seeds within 48 hours prior to dosing.\n* Receipt of a COVID-19 vaccine within 3 days prior to dosing.\n* Presence of braces, retainers, dentures, partial dentures, or tongue piercings.\n* Use of nitric oxide donors, organic nitrates\u002Fnitrites, antihypertensive medications, or PDE5 inhibitors within 14 days of dosing.\n* Blood pressure or heart rate outside acceptable ranges:\n\n  * Systolic BP \\\u003C90 or \\>140 mmHg\n  * Diastolic BP \\\u003C50 or \\>90 mmHg\n  * Heart rate \\\u003C50 or \\>100 bpm",{"count":156,"type":21},72,[51],"The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are:\n\nDo Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products?\n\nAre there any differences in safety or tolerability between the products?\n\nResearchers will compare multiple formulations to evaluate differences in drug absorption and side effects.",[27],[161,162,163,164],"erectile dysfunction","Viagra","sildenafil","tadalafil","2025-12-05",{"date":167,"type":32},"2025-12-12",{"date":169,"type":21},"2026-01",{"date":171,"type":21},"2026-03",{"name":38,"class":39},1,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":192,"locationsCount":4},"100610715","phase-2-phase-2-efficacy-study-of-sildenafil-products-in-adult-men-with-erectile-dysfunction-100610715","NCT07231185","Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction","A Phase 2 Open-Label Study to Evaluate the Efficacy, Safety, and Treatment Experience of Hezkue® and Hezkue Turbo® Compared With Select Commercially Available Sildenafil Products in Adult Men With Erectile Dysfunction (ED)","Inclusion Criteria:\n\n* Male, 18 to 70 years of age.\n\nDocumented diagnosis of erectile dysfunction (ED) for at least 3 months, confirmed by a clinician.\n\nBaseline International Index of Erectile Function-Erectile Function (IIEF-EF) domain score ≤25.\n\nSexually active and attempting sexual intercourse at least 4 times per month during the 3 months prior to screening.\n\nWilling and able to attempt sexual intercourse at least once per week during the study.\n\nJudged by the Investigator to be in good general health other than ED.\n\nCreatinine clearance (CrCl) \\>80 mL\u002Fmin as calculated by Cockcroft-Gault.\n\nAble and willing to comply with all study procedures, including use of eDiary\u002FePRO tools and adherence to dosing instructions.\n\nExclusion Criteria:\n\n* Use of nitrates or nitric oxide donors in any form.\n\nUse of prohibited antihypertensive medications as defined in the protocol.\n\nUse of phosphodiesterase type 5 (PDE5) inhibitors within 5 days prior to baseline.\n\nUse of CYP450 inhibitors within 14 days prior to first dose.\n\nUse of CYP450 inducers or St. John's Wort within 28 days prior to first dose.\n\nUse of any prescription or non-prescription medications, herbal products, or dietary supplements not approved by the Investigator during the required restriction period.\n\nKnown hypersensitivity to sildenafil, tadalafil, vardenafil, peppermint oil, or any component of the investigational product.\n\nClinically significant abnormalities in screening laboratory tests, vital signs, or electrocardiograms, as judged by the Investigator.\n\nAny hepatic impairment or abnormal liver function test results at screening.\n\nPositive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nClinically significant illness within 30 days prior to the first dose.\n\nSignificant cardiovascular disease, including recent myocardial infarction, unstable angina, uncontrolled hypertension, or severe arrhythmias.\n\nHistory of stroke or neurological disorder that may affect sexual function.\n\nSevere psychiatric disorder or substance abuse that may interfere with study participation.\n\nAnatomical penile deformity (such as Peyronie's disease) that may interfere with erectile function assessments.\n\nPositive urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine (PCP), or MDMA.\n\nAlcohol consumption exceeding 15 units per week.\n\nInitiation of new nicotine products during the study period.\n\nParticipation in another clinical trial (other than Hezkue\u002FHezkue Turbo studies) within 30 days prior to screening.\n\nBlood donation or significant blood loss within 3 months prior to screening, or plasma donation within 14 days prior to screening.\n\nMajor surgery within 3 months or minor surgery within 1 month before screening.\n\nConsumption of Seville oranges, grapefruit, or pomelo within 7 days before dosing.\n\nResting systolic blood pressure outside 90-140 mmHg, diastolic blood pressure outside 50-90 mmHg, or heart rate outside 50-100 beats per minute at screening.\n\nSexual partner is pregnant or unwilling to use effective contraception during the study.\n\nAny condition that, in the Investigator's opinion, would make the participant unsuitable for the study.\n\nInstitutionalized individuals.",{"count":182,"type":21},200,[24],"The goal of this clinical trial is to learn how different sildenafil-based erectile dysfunction (ED) treatments affect erectile function in adult men. The main questions it aims to answer are:\n\nDoes each assigned product improve erectile function over 12 weeks?\n\nWhat safety or tolerability issues occur when these products are used on an on-demand basis?\n\nResearchers will compare Hezkue® and Hezkue Turbo® with several commercially available sildenafil or sildenafil-plus-tadalafil products to see whether there are differences in effectiveness, treatment experience, or safety.\n\nParticipants will:\n\n* Use one assigned ED treatment on demand for 12 weeks\n* Complete electronic diaries and questionnaires about sexual-encounter outcomes and treatment satisfaction\n* Attend study visits for safety checks, laboratory tests, and assessments of erectile function",[27],[161,162,163],"2025-11-17",{"date":189,"type":32},"2025-11-19",{"date":169,"type":21},{"date":171,"type":21},{"name":38,"class":39},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":47,"sex":16,"minAge":200,"maxAge":18,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":173},"100583172","phase-1-the-objective-of-this-phase-1-study-is-to-evaluate-the-food-effect-of-100-mg-hezkue-turbo-asp-0011-sildenafil-under-fed-versus-100-mg-of-hezkue-turbo-asp-0011-sildenafil-under-fasted-conditions-in-healthy-adult-male-subjects-100583172","NCT06872866","The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects","A Phase 1 Food-Effect Study of 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* The participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.\n* Participants must be healthy male volunteers aged 20 to 70 years (inclusive) at the time of dosing.\n* Participants must have a body mass index between 18.0 and 29.9 kg\u002Fm² (inclusive) and a body weight of 50 to 100 kg (inclusive).\n* Participants must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.\n* Participants must have a creatinine clearance (CrCl) value greater than 80 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n* Participants must agree to practice an acceptable method of contraception as outlined in the protocol.\n\nExclusion Criteria:\n\n* Unwillingness or inability to follow the procedures specified by the protocol.\n* Participant received any investigational drug\u002Fproduct within 30 days prior to the first dose.\n* History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, inflammatory, infectious, diabetes mellitus, or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the study.\n* Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator and\u002For designee.\n* Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST, bilirubin, alkaline phosphatase, prothrombin time and international normalized ratio during screening).\n* Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.\n* Reports a clinically significant illness during the 28 days prior to first dose (as determined by the Investigator and\u002For designee).\n* Subjects with known hypersensitivity to sildenafil or any component in the study medication, such as peppermint oil.\n* Reports a history of clinically significant allergies including food or drug allergies as judged by the Investigator.\n* History of drug abuse within the previous year, or a positive drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, Cocaine, Opiates, Phencyclidine, 3,4-methylenedioxymethamphetamine (MDMA)) at screening and\u002For Day -1.\n* Regular alcohol consumption of \\>15 units per week, with one unit being equivalent to 330 mL of beer or 125 mL of wine or 25 mL to 40 mL of ≥ 40% spirits, or a positive alcohol breathalyzer test at screening and\u002For Day -1.\n* Reports use of CYP enzyme inhibitors within 14 days prior to Period 1 dosing.\n* Reports use of CYP enzyme inducers or St. John's Wort within 28 days prior to Period 1 dosing.\n* Use of prescription or non-prescription drugs, including individual vitamins, herbal and dietary supplements within seven days or five half-lives, whichever is longer, unless in the opinion of the Investigator and Sponsor's medical monitor the medication is not expected to interfere with the study procedures or compromise subject safety (occasional use of acetaminophen, naproxen, and ibuprofen are allowed).\n* Blood donation or significant blood loss within 3 months before screening. All volunteers will be advised not to donate blood for 30 days after completing the study.\n* Reports donating plasma within 14 days prior to first dose. All volunteers will be advised not to donate plasma for 30 days after completing the study.\n* Demonstrates, in the opinion of study staff, inadequate veins or veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).\n* Reports difficulty fasting or consuming standardized meals.\n* Reports intolerance to fatty foods or cannot consume a high-calorie and high-fat breakfast.\n* Subjects who have difficulty swallowing.\n* Regular use of tobacco (\\>4 cigarettes per day) or nicotine-containing products within four weeks before screening, or urinary cotinine level indicative of active smoking at screening and\u002For Day -1\n* Major surgery within three months or minor surgery within one month before screening as per the Principal Investigator (PI) judgment.\n* If, in the opinion of the PI, the subject is not suitable for the study.\n* Subject administered COVID-19 vaccine within three days prior to each check-in.\n* Subjects with retainers, braces, dentures, partial dentures, and\u002For tongue piercing.\n* Subjects using the following within 14 days of first dose:\n* Nitric oxide donors, such as organic nitrates or organic nitrites in any form\n* Antihypertensive medications\n* PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)\n\nSubjects with known hypertension or blood pressure and heart rate outside of the following ranges:\n\n* Systolic blood pressure: 90 - 140 mmHg\n* Diastolic blood pressure: 50 - 90 mmHg\n* Heart rate at screening: 50 - 100 beats per minute\n* Institutionalized volunteers.\n* Reports use of any hormone replacement therapy within 6 months prior to first dose.\n* Use of any products containing Seville oranges, grapefruit and pomelo within seven days prior to first dose and for the duration of the study.\n* Ingestion of any caffeine\u002Fxanthine containing products (coffee, tea, soft drinks, chocolate, energy drinks, etc.), foods containing poppy seeds within 48 hours prior to first dose and for the duration of the study.\n* Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit-ades, or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to first dose and for the duration of the study.","20 Years",{"count":202,"type":21},12,[51],"The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects",[27],[161,207,163],"viagra","RECRUITING",{"date":189,"type":32},{"date":211,"type":32},"2025-04-15",{"date":213,"type":21},"2026-02-28",{"name":38,"class":39},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100576235","phase-1-study-to-compare-the-effects-of-viagra-vs-hezkue-in-healthy-fasted-male-participants-100576235","NCT06782659","Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.","A Phase 1 Pharmacokinetic\u002FBioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* The participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.\n* Participants must be healthy male volunteers aged 18 to 55 years (inclusive) at the time of dosing.\n* Participants must have a body mass index between 18.0 and 29.9 kg\u002Fm² (inclusive) and a body weight of 50 to 100 kg (inclusive).\n* Participants must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.\n* Participants must have a creatinine clearance (CrCl) value greater than 80 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n* Participants must agree to practice an acceptable method of contraception as outlined in the protocol.\n\nExclusion Criteria:\n\n* Unwillingness or inability to follow the procedures specified by the protocol.\n* Participant received any investigational drug\u002Fproduct within 30 days prior to the first dose.\n* History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, inflammatory, infectious, diabetes mellitus, or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the study.\n* Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator and\u002For designee.\n* Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST, bilirubin, alkaline phosphatase, prothrombin time and international normalized ratio during screening).\n* Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.\n* Reports a clinically significant illness during the 28 days prior to first dose (as determined by the Investigator and\u002For designee).\n* Subjects with known hypersensitivity to sildenafil or any component in the study medication, such as peppermint oil.\n* Reports a history of clinically significant allergies including food or drug allergies as judged by the Investigator.\n* History of drug abuse within the previous year, or a positive drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, Cocaine, Opiates, Phencyclidine, 3,4-methylenedioxymethamphetamine (MDMA)) at screening and\u002For Day -1.\n* Regular alcohol consumption of \\>15 units per week, with one unit being equivalent to 330mL of beer or 125 mL of wine or 25 mL to 40 mL of ≥ 40% spirits, or a positive alcohol breathalyzer test at screening and\u002For Day -1.\n* Reports use of CYP enzyme inhibitors within 14 days prior to Period 1 dosing.\n* Reports use of CYP enzyme inducers or St. John's Wort within 28 days prior to Period 1 dosing.\n* Use of prescription or non-prescription drugs, including individual vitamins, herbal and dietary supplements within seven days or five half-lives, whichever is longer, unless in the opinion of the Investigator and Sponsor's medical monitor the medication is not expected to interfere with the study procedures or compromise subject safety (occasional use of acetaminophen, naproxen, and ibuprofen are allowed).\n* Blood donation or significant blood loss within 3 months before screening. All volunteers will be advised not to donate blood for 30 days after completing the study.\n* Reports donating plasma (e.g., plasmapheresis) within 14 days prior to first dose. All volunteers will be advised not to donate plasma for 30 days after completing the study.\n* Demonstrates, in the opinion of study staff, inadequate veins or veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).\n* Reports difficulty fasting or consuming standardized meals.\n* Subjects who have difficulty swallowing.\n* Regular use of tobacco (\\>4 cigarettes per day) or nicotine-containing products within four weeks before screening, or urinary cotinine level indicative of active smoking at screening and\u002For Day -1\n* Major surgery within three months or minor surgery within one month before screening as per the Principal Investigator (PI) judgment.\n\nIf, in the opinion of the PI, the subject is not suitable for the study.\n\n* Institutionalized volunteers.\n* Reports use of any hormone replacement therapy within 6 months prior to first dose.\n* Use of any products containing Seville oranges, grapefruit and pomelo within seven days prior to first dose and for the duration of the study.\n* Ingestion of any caffeine\u002Fxanthine containing products (coffee, tea, soft drinks, chocolate, energy drinks, etc.), foods containing poppy seeds within 48 hours prior to first dose and for the duration of the study.\n* Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit-ades, or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to first dose and for the duration of the study.\n* Subject administered COVID-19 vaccine within three days prior to each check-in.\n* Subjects with retainers, braces, dentures, partial dentures, and\u002For tongue piercing.\n* Subjects using the following within 14 days of first dose:\n\n  * Antihypertensive medications.\n  * PDE5 inhibitors\n* Subjects with known hypertension or blood pressure and heart rate outside of the following ranges:\n\n  * Systolic blood pressure: 90 - 140 mmHg\n  * Diastolic blood pressure: 50 - 90 mmHg\n  * Heart rate at screening: 50 - 100 beats per minute",{"count":223,"type":21},56,[51],"The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers",[27],[228,162,229,230],"Erectile dysfunction","Sildenafil","bioequivalence","2025-01-16",{"date":233,"type":32},"2025-01-20",{"date":235,"type":21},"2025-01",{"date":237,"type":21},"2025-03",{"name":38,"class":39},2,""]