Status:
COMPLETED
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (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 artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (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 :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00894374
Start Date
June 1 2009
End Date
August 1 2009
Last Update
June 25 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Singapore, Singapore, Singapore, 188770