Healthy Clinical Trial
Official title:
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Subjects
The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
This is an open-label (the participant and the study physician know what the participant is getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study in approximately 16 healthy adult participants. Participants will receive study medication under fed state first and later under fasted state or vice versa. The study consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study physician will check participant's general health during the study. Total duration of study for each participant will be approximately 48 days. ;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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