Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effect of food on the absorption of the drug as well as safety
and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering
from chronic Chagas' disease when administered after a high-fat / high-calorie test meal
(American breakfast) compared to a fasting state. This study is required as part of the
clinical 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).