Pilot randomized crossover comparative bioavailability study of tadalafil oral suspension versus film-coated tablets after single-dose administration in healthy male volunteers

This study is a pilot, randomized, crossover, comparative bioavailability study evaluating two different formulations of tadalafil, specifically an oral suspension and film-coated tablets. The primary objective is to compare the pharmacokinetic profile of these two formulations following a single 20 mg dose under fasting conditions in healthy male volunteers. Determining the equivalence of these delivery methods is clinically relevant for ensuring consistent drug absorption and systemic exposure. No secondary objectives are specified.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 45 years. The cohort is composed of males.

This is a Phase 3, pilot, randomized, crossover, comparative bioavailability study. The research evaluates two tadalafil formulations, specifically an oral suspension and film-coated tablets, following a single 20 mg dose administered under fasting conditions. The study involves healthy male volunteers. The methodology utilizes a crossover design to compare the pharmacological profiles of both formulations. The trial procedures include a screening visit to assess eligibility, followed by necessary study visits to monitor the administration and effects of the doses. The study concludes with an end-of-study visit. The total estimated duration for the trial period is from May 1, 2026, to June 12, 2026.

The provided information does not contain data regarding the parameters, methods, or tools used to assess efficacy for this study involving healthy volunteers.