Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clarithromycin · 4 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Clarithromycin Tablets | EXPERIMENTAL | Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period |
| Biaxin® Tablets | ACTIVE_COMPARATOR | Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period |
| Clarithromycin (test) First | EXPERIMENTAL | - |
| Biaxin® XL (reference) First | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Clarithromycin (test) | EXPERIMENTAL | Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period |
| Biaxin® | ACTIVE_COMPARATOR | Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Clarithromycin | DRUG | 500 mg Tablet |
| Biaxin® | DRUG | 500 mg Tablet |
| Clarithromycin ER 500 mg tablets | DRUG | 1 x 500 mg |
| BIAXIN® XL 500 mg tablets | DRUG | 1 x 500 mg |
Inclusion Criteria: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. Each subject will complete the screening process within 28 days prior to period I dosing. Co...
Clarithromycin is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It has been studied in Phase 1 clinical trials involving healthy adult volunteers. The trials listed for this asset were conducted in the United States and focused on the 500 mg extended release tablet formulation.
The clinical trials of Clarithromycin listed here enrolled healthy volunteers rather than patients with a specific disease, so the studies evaluated the drug in healthy participants. The trials were conducted under both fasting and non-fasting conditions. No specific treatment indication is identified for these studies.
Clarithromycin is developed by Teva Pharmaceutical Industries Limited, which is listed under the ticker TEVA. Teva is the sponsor associated with the Phase 1 trials of the 500 mg extended release tablet and 500 mg tablet formulations of Clarithromycin conducted in the United States.
Clarithromycin is in Phase 1 clinical development according to the trials listed for this asset. All four trials are Phase 1 studies, and all four have completed. There are currently no active trials listed. The studies enrolled healthy volunteers and were conducted in the United States.
Four completed Phase 1 trials are listed for Clarithromycin: NCT00840411 and NCT00835692 evaluated 500 mg tablets under fasting conditions, while NCT00840216 and NCT00836706 evaluated the formulation under non-fasting conditions. Total enrollment across these trials was 172 healthy adult volunteers, with a randomized, active-controlled design.