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

Seattle Gummy Company

Status and phase: Not yet enrolling; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: Tadalafil 10 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT04762082

P-002-2020

Details and patient eligibility

About

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

Full 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 tablets 10 mg (Reference) under fasted conditions in healthy adult male and female subjects, and the impact on the bioavailability of tadalafil gummy sugar free 10 mg when administered with food, when administered with or without water, and when chewed or swallowed whole.

Each subject will receive tadalafil gummy (10 mg) or tadalafil tablet and thereby will be his/hers own control.

Enrollment: 30 estimated patients

Sex: Male

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Treatment A: Test

Experimental group

Description:

Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions

Treatment:

Drug: Tadalafil 10 MG

Treatment B: Reference

Active Comparator group

Description:

Single oral dose of tadalafil oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions

Treatment:

Drug: Tadalafil 10 MG

Treatment C: Test

Experimental group

Description:

Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions

Treatment:

Drug: Tadalafil 10 MG

Treatment D: Test

Experimental group

Description:

Single oral dose of tadalafil gummy 10 mg, chewed, administered with no water, under fasted conditions

Treatment:

Drug: Tadalafil 10 MG

Treatment E: Test

Experimental group

Description:

Single oral dose of tadalafil gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions

Treatment:

Drug: Tadalafil 10 MG