[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421000":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":38,"locations":37,"responsibleParty":44,"collaborators":37,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":37,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":37,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":37,"overallStatus":65,"whyStopped":37,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":37},{"fullName":5,"class":6},"Seattle Gummy Company","INDUSTRY",[8,14,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A: Test","EXPERIMENTAL","Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions",[13],"Drug: Tadalafil 10 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment B: Reference","ACTIVE_COMPARATOR","Single oral dose of tadalafil oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Treatment C: Test","Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Treatment D: Test","Single oral dose of tadalafil gummy 10 mg, chewed, administered with no water, under fasted conditions",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Treatment E: Test","Single oral dose of tadalafil gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions",[13],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Tadalafil 10 MG","comparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg",[9,15,20,24,28],null,[39],{"name":40,"role":41,"phone":42,"phoneExt":37,"email":43},"President","CONTACT","2062570464","clinicaltrial@seattlegummy.com",{"type":45,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"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",[64],"Erectile Dysfunction","NOT_YET_RECRUITING","2024-06-12",{"date":68,"type":69},"2024-06-13","ACTUAL",{"date":71,"type":58},"2025-05-01",{"date":73,"type":58},"2025-12-30",{"name":5,"class":6}]