Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-02-28 @ 3:38 PM
Study NCT ID:
NCT03708133
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation
Sponsor:
Bayer
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
In addition, the PK, safety, and tolerability of nifurtimox will be assessed as secondary objectives.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: