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.
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AUC of nifurtimox in plasma
Timeframe: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose
AUC(0-tlast) of nifurtimox in plasma
Timeframe: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose
Cmax of nifurtimox in plasma
Timeframe: Pre-dose (up to 30 minutes before study drug administration), and at 15 minutes, 30 minutes, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 15 hours post-dose