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

NCT01927224 Phase 1 COMPLETED

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).

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	37
Start date	2013-11
Completion	2014-09

Conditions

• Chagas Disease

Interventions

• Nifurtimox (BAYa2502) (4 x 30 mg tablet)
• Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water)
• Nifurtimox (BAYa2502) (120 mg tablet)

Primary outcomes

• Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point [AUC(0-tn)] — 0-24 hours
• Maximum drug concentration of nifurtimox in plasma (Cmax) — Up to 24 hours

Countries

Argentina