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Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation

NCT03708133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-11

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2019-04-17
Completion
2019-06-18

Countries

  • Argentina

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708133 on ClinicalTrials.gov