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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835146 | Ribavirin 200 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Sep 1, 2003 | Oct 1, 2003 | Aug 20, 2024 | 2 | United States |
| NCT00835536 | Ribavirin 200 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 27 | — | — | Sep 1, 2003 | Oct 1, 2003 | Aug 20, 2024 | 2 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-72.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ribavirin 200 mg tablets | DRUG | 1 x 200 mg, single-dose fasting |
| COPEGUS™ | DRUG | 1 x 200 mg, single-dose fasting |
| COPEGUS™ 200 mg Tablets | DRUG | 1 x 200 mg, single-dose non-fasting |
Inclusion Criteria: * All subjects selected for this study will be non-smokers, at least 18 years of age, and a female whi is physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile). Subjects will have a BMI (body mass index) of 30 or less. * Each subject s...