[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Seattle Gummy Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"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},"100421000","phase-1-a-single-dose-randomized-five-way-crossover-pharmacokinetics-pk-study-of-tadalafil-semi-chewable-gummy-formulations-in-healthy-volunteers-100421000",false,"NCT04762082","A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers","Inclusion Criteria:\n\n* male 19-65 years of age;\n* Available to participate for the planned duration of the study;\n* Able and willing to complete the informed consent process;\n* Agree to have blood samples collected and stored for the study;\n* Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the course of the study;\n* Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to the study;\n* Have not taken nitrates, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors and CYP3A4 inducers for a specified duration of time prior to the study;\n* Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of the study.\n\nExclusion Criteria:\n\n* A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access;\n* A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;\n* subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;\n* Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;\n* Currently taking any medicines known to conflict with tadalafil;\n* History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study;\n* History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor;\n* History of diabetes;\n* History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study;\n* Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.",true,"MALE","19 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers",[27],"Erectile Dysfunction","NOT_YET_RECRUITING","2024-06-12",{"date":31,"type":32},"2024-06-13","ACTUAL",{"date":34,"type":21},"2025-05-01",{"date":36,"type":21},"2025-12-30",{"name":38,"class":39},"Seattle Gummy Company","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":15,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":45,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100368017","phase-1-relative-bioavailability-study-to-evaluate-cetirizine-hcl-gummy-10-mg-and-cetirizine-hcl-oral-tablets-10-mg-100368017","NCT04071821","Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg","A Randomized, Open-Label, Single-Dose, Five-Period Crossover, Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Administered in Healthy Adult Male and Female Subjects","Inclusion Criteria:\n\n1. Are capable of giving informed consent and complying with study procedures;\n2. Male or female, 18 to 55 years of age, inclusive, at date of consent;\n3. Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg\u002Fm2 and total body weight \\> 50 kg (110 lbs.) at Screening;\n4. All female subjects must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:\n\n   1. Using a medically acceptable form of birth control for at least 1 month prior to first dose \\[e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), intrauterine device, or a double barrier method (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)\\]\n   2. Documented as surgically sterile by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Ftubal occlusion) at least 6 months prior to the first dose;\n   3. Postmenopausal (no menstruation for a minimum of 12 months and confirmed by FSH and estradiol at Screening);\n5. Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination;\n6. Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose.\n7. Be willing and able to consume all contents of the standardized high calorie, high fat breakfast within 30 minutes prior to dosing.\n\nExclusion Criteria:\n\n1. Females who are pregnant, lactating, or planning to become pregnant during the study;\n2. Life-time history and\u002For recent evidence of alcohol or drug\u002Fsubstance abuse disorder;\n3. Subjects with history of hypersensitivity to cetirizine or hydroxyzine, or any component of the test and reference formulations;\n4. Subjects who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody;\n5. Subjects who test positive at Screening or at Check-in for alcohol and\u002For drugs of abuse;\n6. Subjects who donated ≥ 500 mL of blood within 56 days prior to the first dose of study drug or ≥ 50 mL and ≤ 499 mL of blood within 30 days or plasma (e.g. plasmapheresis) within 14 days prior to the first dose of study drug;\n7. Use of prescription or non-prescription drugs, dietary supplements, or herbal supplements at the time of Screening and within 14 days prior to the first dose of the study drug;\n8. Subjects who have a history of difficulty in donating blood or difficulty with phlebotomy procedures, and poor venous access;\n9. Subjects who have participated in another clinical trial within 30 days prior to the first study period;\n10. Member or first-degree relative of study staff or the Sponsor directly involved in the study;\n11. Any condition which in the opinion of Investigator would interfere with the subject's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the subject if he or she took part in the trial.","ALL","18 Years","55 Years",{"count":20,"type":21},[24],[53],"Allergy",{"date":31,"type":32},{"date":34,"type":21},{"date":57,"type":21},"2025-09-30",{"name":38,"class":39},""]