check_circleStudy Completed
Chagas disease
Bayer Identifier:
16004
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to assess bioequivalence of 30 and 120 mg Nifurtimox tablets in chronic Chagas’ patients
Trial purpose
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).
Key Participants Requirements
Sex
BothAge
18 - 45 YearsTrial summary
Enrollment Goal
37Trial Dates
November 2013 - September 2014Phase
Phase 1Could I Receive a placebo
NoProducts
Lampit (Nifurtimox, BAYA2502)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | FP Clinical Pharma | Buenos Aires, C1425BAB, Argentina |
Primary Outcome
- Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point [AUC(0-tn)]date_rangeTime Frame:0-24 hoursenhanced_encryptionNoSafety Issue:
- Maximum drug concentration of nifurtimox in plasma (Cmax)date_rangeTime Frame:Up to 24 hoursenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 8 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2