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 antibiotic being studied in healthy volunteers. It is currently in Phase 1 clinical development by Teva Pharmaceutical Industries Limited. The drug is being evaluated in tablet and extended release tablet formulations under fasting and non-fasting conditions.
Teva Pharmaceutical Industries Limited (TEVA) is developing Clarithromycin. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers in the United States. All four trials listed for Clarithromycin have been completed.
Clarithromycin is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers. The four clinical trials for Clarithromycin have all been completed, with a total enrollment of 172 participants across the studies.
Clarithromycin has four completed Phase 1 clinical trials: NCT00835692 (fasting, 60 participants), NCT00836706 (non-fasting, 24 participants), NCT00840216 (extended release, non-fasting, 22 participants), and NCT00840411 (extended release, fasting, 66 participants). All trials were conducted in the United States with healthy adults aged 18 years and older.
Clarithromycin is an investigational drug in Phase 1 clinical development. It has not been reported as FDA approved. The drug is being studied in healthy volunteers to evaluate its pharmacokinetics under various conditions, including fasting and non-fasting states.