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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00836004 | Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions | PHASE1 | COMPLETED | 24 | — | — | Nov 1, 2003 | Nov 1, 2003 | Aug 19, 2024 | 1 | Canada |
| NCT00836056 | Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Nov 1, 2003 | Nov 1, 2003 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUCinf
Bioequivalence based on AUC0-t
Cmax - Maximum Observed Concentration
AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
| Arm | Type | Description |
|---|---|---|
| Clindamycin (test) | EXPERIMENTAL | Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period |
| Cleocin® (reference) | ACTIVE_COMPARATOR | Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Clindamycin 300 mg capsule | DRUG | 1 x 300 mg |
| Cleocin HCl 300 mg capsules | DRUG | 1 x 300 mg |
Inclusion Criteria: * Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age. * Non-child-bearing potential female subject is defined as follows: 1. Post-menopausal state: absence of menses for 12 months prior to drug administration or hyster...