NCT04762082

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seattle Gummy Company · Industry
• Sex: Male
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Tadalafil 10 MG	comparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-30
• Completion: 2025-12-30
• First posted: 2021-02-21
• Last updated: 2024-06-13

Regulatory

• FDA-regulated drug study