Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Phase 1
Completed
- Conditions
- Falciparum Malaria
- Interventions
- Registration Number
- NCT00894374
- Lead Sponsor
- Pfizer
- Brief Summary
The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
- Evidence or history of clinically significant abnormalities.
- A positive urine drug screen, history of regular alcohol consumption.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Artesunate (Pfizer) Artesunate (Test) - Artesunate (Arsuamoon® Tablets Guilin-China) Artesunate (Comparator) -
- Primary Outcome Measures
Name Time Method AUC and Cmax of active metabolite of artesunate 30-Aug-2009
- Secondary Outcome Measures
Name Time Method Tolerability 30-Aug-2009
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore