Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00894374 | Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects | PHASE1 | COMPLETED | 40 | — | — | Jun 1, 2009 | Aug 1, 2009 | Jun 25, 2010 | 1 | Singapore |
| Arm | Type | Description |
|---|---|---|
| Artesunate (Pfizer) | EXPERIMENTAL | - |
| Artesunate (Arsuamoon® Tablets Guilin-China) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Artesunate (Test) | DRUG | Oral tablet, single dose, 1 x 100 mg |
| Artesunate (Comparator) | DRUG | Oral tablet, single dose, 2 x 50 mg |
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: *...