Bioequivalence Clinical Trial
Official title:
Open-label, Randomized, Single-dose, Cross-over Study to Assess Bioequivalence Between a Single 120 mg Nifurtimox Tablet and a Newly Developed 120 mg Nifurtimox Tablet, Administered Orally Under Fed Conditions to Adult Male and Female Patients With Chronic Chagas' Disease
The primary objective of the current study is to investigate the bioequivalence of a newly
developed 120 mg nifurtimox tablet formulation (Test treatment) compared with the 120 mg
nifurtimox tablet currently used in the Bayer pediatric clinical development program
(Reference treatment). The new tablet formulation assessed in this study is intended to
replace the 120 mg nifurtimox tablet formulation currently used in clinical practice. It is
an immediate-release tablet with an altered composition compared to the reference
formulation. The new tablet overcomes pharmaceutical quality issues seen for the current
formulation, e.g. sensitivity to humidity. Due to safety reasons, the study drug will be
administered under fed conditions to adult male and female patients suffering from Chagas'
disease and not healthy subjects (see also Benefit-risk assessment below).
In addition, the PK, safety, and tolerability of nifurtimox will be assessed as secondary
objectives.
n/a
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