Chagas Disease Clinical Trial
Official title:
Open Label, Randomized, Single-dose, Cross-over Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg Tablets, Administered to Adult Male and Female Patients With Chagas' Disease
Study to assess the relative Bioavailability To assess the relative bioavailability of three formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles To assess the pharmacokinetics (PK) of nifurtimox To investigate the safety and tolerability of nifurtimox.
Primary objective is to assess the relative bioavailability of three formulations of
nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles (slow, medium,
and fast, whereby "medium" represents the drug product currently used in clinical Phase 3
studies) under fed conditions in adult male and female patients with Chagas' disease.
A secondary objective of the study is to assess the relative bioavailability of nifurtimox
after a single oral dose of 30 mg and 120 mg To assess the pharmacokinetics (PK) of
nifurtimox To investigate the safety and tolerability of nifurtimox..
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