Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cleocin · 2 trials · 1 indication
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...
Cleocin is a small molecule drug being developed by Teva Pharmaceutical Industries Limited. It is currently in Phase 1 clinical trials for use in healthy subjects. The drug is being studied in bioavailability and pharmacokinetic trials to assess how it behaves in the body under fed and fasting conditions.
Cleocin is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development for use in healthy subjects.
Cleocin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
Cleocin has been studied in two completed Phase 1 clinical trials. NCT00836004 evaluated Clindamycin 300 mg capsules in healthy subjects under fed conditions, and NCT00836056 evaluated the same dose under fasting conditions. Both trials were conducted in Canada with 24 participants each.
Cleocin is a brand name for clindamycin, an antibiotic. The clinical trials for Cleocin listed in the data refer to clindamycin 300 mg capsules. The drug is being studied in healthy subjects to assess its pharmacokinetics under fed and fasting conditions.