Approval Probability
TA Base Rate
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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
Zithromax · 1 trial · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Azithromycin (test) | EXPERIMENTAL | Azithromycin 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® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Azithromycin | OTHER | Oral Suspension |
| Zithromax® | DRUG | Oral Suspension |
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...
Zithromax is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is also known as Zithromax or Zithromax 600 mg Tablet. The listed development stage is Phase 1, and the specific indications being studied are undisclosed.
Zithromax is developed by Teva Pharmaceutical Industries Limited, a company that trades under the ticker TEVA. Teva is the sponsor associated with the clinical development program for this small molecule asset.
Zithromax is listed as being in Phase 1 development. It is an investigational small molecule and is not described as approved. The program has one recorded trial, which is completed, with no active trials currently listed.
Zithromax has one recorded clinical trial, NCT00830206, titled A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions. It was a Phase 1, active-controlled, randomized study with 80 enrolled participants, conducted in the United States in healthy volunteers, and it is completed.
The indications for Zithromax are undisclosed. The only recorded trial, NCT00830206, enrolled healthy volunteers rather than patients with a specific disease, and it evaluated relative bioavailability of a 200mg/5 mL azithromycin oral suspension under fasting conditions in the United States.