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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04762082
Study type Interventional
Source Seattle Gummy Company
Contact President
Phone 2062570464
Email clinicaltrial@seattlegummy.com
Status Not yet recruiting
Phase Phase 1
Start date May 1, 2025
Completion date December 30, 2025

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