Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. FDA label
Azithromycin · 3 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Azithromycin (test) | EXPERIMENTAL | Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period |
| Zithromax® (reference) | ACTIVE_COMPARATOR | Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period |
| Azithromycin | EXPERIMENTAL | Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period |
| Zithromax® | ACTIVE_COMPARATOR | Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Azithromycin | DRUG | Oral Suspension |
| Zithromax® | DRUG | Oral Suspension |
| Azithromycin 600 mg Tablet | DRUG | 1 x 600mg, single-dose fasting |
| Zithromax® 600 mg Tablet | DRUG | 1 x 600mg, single-dose fasting |
Inclusion Criteria * Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be between 19 and 30. * Screening Procedures: Each subject will complete the screening process w...
Azithromycin is a small molecule drug developed by Teva Pharmaceutical Industries Limited under the ticker TEVA. It is being studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat are undisclosed. The trials completed so far have enrolled healthy adult volunteers, not patients with a particular disease.
Azithromycin is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials evaluating this drug. The development program includes three completed Phase 1 studies conducted in the United States.
Azithromycin is in Phase 1 clinical development. Three Phase 1 trials have been completed, and no active trials are currently listed. The completed studies enrolled a total of 140 participants. The program remains investigational and has not been approved for any indication based on the available development information.
Azithromycin has been evaluated in three completed Phase 1 trials: NCT00834756, a fasting study with 36 healthy participants; NCT00834132, a fed study with 24 healthy participants; and NCT00830336, a relative bioavailability study of a 200 mg/5 mL oral suspension under non-fasting conditions with 80 healthy participants. All were conducted in the United States.