Safety and Pharmacokinetics Study of AD-116 and AD-1161 in Healthy Adult Males Under Fed Conditions Using a Randomized Two-Period Crossover Design

What this Trial Is About

This clinical trial is focused on healthy adult male volunteers to evaluate the safety and pharmacokinetics of two drugs, AD-116 and AD-1161, under fed conditions. The study is a Phase 1, open-label, randomized, single-dose crossover trial aimed at understanding how these drugs behave in the body when taken with food. It specifically targets males aged 19 years and older who meet health criteria. Participants receive single doses of AD-116 or AD-1161 according to a randomized sequence in two study periods. In one sequence, the reference drug, Duodart capsule, is given first followed by the test drug AD-1161, which contains dutasteride 0.5 mg and tamsulosin 0.4 mg. In the other sequence, the order is reversed. Each drug is administered orally once during its respective period. During the trial, researchers measure drug concentration over time by tracking the area under the plasma concentration-time curve (AUCt) and the maximum concentration (Cmax) from pre-dose to 72 hours post-dose. Participants are monitored for safety and drug effects throughout the study. The total duration includes two dosing periods with assessments extending up to 72 hours after each dose to fully evaluate drug absorption and safety under fed conditions.

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects