Status:
COMPLETED
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Lead Sponsor:
Pfizer
Conditions:
Falciparum Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
Exclusion
- A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00859807
Start Date
May 1 2009
End Date
June 1 2009
Last Update
April 21 2010
Active Locations (1)
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1
Pfizer Investigational Site
Navi Mumbai, Maharashtra, India, 400709