Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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).