Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of
the tablet formulation used in the clinical trials and the final marketed tablet formulation
under fed condition.
The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate
crossover study under fed condition. The 4-period sequences for the replicate design will be
TRTR and RTRT, where R designates the reference formulation and T the test formulation.
Subject will be allocated randomly to one of the two sequences of treatments according to the
randomization list.