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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00894660 | A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects | PHASE1 | COMPLETED | 38 | — | — | Jun 1, 2009 | Jul 1, 2009 | Apr 21, 2010 | 1 | Singapore |
| Arm | Type | Description |
|---|---|---|
| Amodiaquine (Pfizer) | EXPERIMENTAL | - |
| Amodiaquine tablets (Arsuamoon-Guilin China) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Amodiaquine (Test) | DRUG | Oral tablet, single dose, 1 X 300 MG |
| Amodiaquine (Comparator) | DRUG | Oral tablet, single dose, 2 X 150 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: *...