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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
Unnamed facility
Merksem, Belgium
Concentration of mebendazole in blood and urine under fed and fasted condition
Time frame: Up to Day 5 of in each treatment period
Number of participants with adverse events
Time frame: From screening up to 7 to 10 days after Day 5 of Treatment Period 2
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