NCT03708133

Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Nifurtimox (Lampit, BAYA2502)_Test	Orally intake of 1 \*120mg new formulation tablet as test treatment
DRUG	Nifurtimox (Lampit, BAYA2502)_Reference	Orally intake of 1 \*120mg current clinical formulation tablet as reference treatment

Timeline

• Start date: 2018-12-05
• Primary completion: 2019-04-17
• Completion: 2019-06-18
• First posted: 2018-10-17
• Last updated: 2020-06-11

Locations

1 site across 1 country: Argentina