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The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 | Experimental |
| |
| 2.0 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artesunate sachets | Drug | single dose 50 mg (2 X 25 mg) artesunate sachets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, AUCinf and AUClast, for DHA | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate. | 1 year | |
| Safety laboratory tests, vital signs, and adverse events. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Navi Mumbai | Maharashtra | 400709 | India |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Arsuamoon |
| Drug |
single dose 50 mg arsuamoon tablet |
|