check_circleStudy Completed

Chagas disease

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

Both

Age

18 - 45 Years

Trial summary

Enrollment Goal
37
Trial Dates
November 2013 - September 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Lampit (Nifurtimox, BAYA2502)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
FP Clinical PharmaBuenos 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 hours
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    Safety Issue:
    No
  • Maximum drug concentration of nifurtimox in plasma (Cmax)
    date_rangeTime Frame:
    Up to 24 hours
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    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 8 weeks
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    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2