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Bioequivalence of Artesunate Sachets vs Arsuamoon Tablets
NCT00875030Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2009
- Primary completion
- Jun 2009
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- artesunate
- Conditions
- malaria
01
Overview
Phase 4, randomised, open-label trial of artesunate in malaria (2 arms), sponsored by Pfizer. Primary endpoints: Maximum Plasma Concentration at 1 year, Area Under the Curve to Infinity at 1 year and 1 more. Started Jun 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Artesunate Sachets
Single dose 50 mg (2x25 mg) artesunate sachets
Arsuamoon
Single dose 50 mg Arsuamoon tablet
03
Who it enrols
Healthy male and/or female subjects between the ages of 18 and 55 years with BMI of 18 to 30 kg/m2.
04
Endpoints
Primary
Maximum Plasma Concentration
Area Under the Curve to Infinity
Area Under the Curve to Last Quantifiable Concentration
Secondary
Time to Maximum Plasma Concentration
Half-Life
Maximum Plasma Concentration
Area Under the Curve to Infinity
Area Under the Curve to Last Quantifiable Concentration
Safety laboratory tests, vital signs, and adverse events
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