NCT01927224

Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients

Open Label, Randomized, Single Dose Cross-over Study to Assess Bioequivalence Between Single 120 mg Nifurtimox Tablet and Four 30 mg Nifurtimox Tablets Administered Orally, Following High Calorie/High Fat Meal to Adult Male and Female Patients Suffering From Chronic Chagas' Disease and to Determine the Pharmacokinetics of Nifurtimox Tablets Administered Orally, in a Form of Aqueous Slurry

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30 mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult subjects suffering from chronic Chagas' disease when administered after a high-fat / high-calorie test meal. This study is a necessary step for the development of an age appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic countries according to the recommendations provided by current international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage Forms).

Conditions

• Chagas Disease

Interventions

Type	Name	Description
DRUG	Nifurtimox (BAYa2502) (4 x 30 mg tablet)	120 mg single dose as four 30 mg tablets after a high fat, high calorie meal
DRUG	Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water)	120 mg single dose as aqueous slurry in tap water produced from four 30 mg tablets; ingestion after a high fat, high calorie meal
DRUG	Nifurtimox (BAYa2502) (120 mg tablet)	120 mg single dose as one 120 mg tablet after a high fat, high calorie meal

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2013-08-22
• Last updated: 2015-10-16

Locations

1 site across 1 country: Argentina