Status:
COMPLETED
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Lead Sponsor:
Pfizer
Conditions:
Falciparum Malaria
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
- 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
- Evidence or history of clinically significant abnormalities.
- A positive urine drug screen, history of regular alcohol consumption.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00894660
Start Date
June 1 2009
End Date
July 1 2009
Last Update
April 21 2010
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, Singapore, 188770