A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seattle Gummy Company
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• male 19-65 years of age;

• Available to participate for the planned duration of the study;

• Able and willing to complete the informed consent process;

• Agree to have blood samples collected and stored for the study;

• Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the course of the study;

• 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;

• Have not taken nitrates, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors and CYP3A4 inducers for a specified duration of time prior to the study;

• 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.

Exclusion Criteria:

• 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;

• A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;

• subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;

• Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;

• Currently taking any medicines known to conflict with tadalafil;

• History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study;

• History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor;

• History of diabetes;

• 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;

• Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.