Status:
NOT_YET_RECRUITING
A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
Lead Sponsor:
Seattle Gummy Company
Conditions:
Erectile Dysfunction
Eligibility:
MALE
19-65 years
Phase:
PHASE1
Brief 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
Detailed Description
This is an open-label, single dose, randomized, five-period, crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg (Test) and tadalafil oral ta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04762082
Start Date
May 1 2025
End Date
December 30 2025
Last Update
June 13 2024
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