Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zithromax · 4 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 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 |
| 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 | OTHER | 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...
Zithromax is an investigational small molecule being studied in healthy volunteers. The clinical trials listed for Zithromax are bioavailability studies of azithromycin oral suspension and tablets under fasting and non-fasting conditions, with healthy participants as the study population.
Zithromax is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials for this drug.
Zithromax is in Phase 1 clinical development. All four clinical trials associated with Zithromax are Phase 1 studies and have been completed. The drug is investigational and not yet approved.
Zithromax has four completed Phase 1 trials: NCT00830206 and NCT00830336 study a 200mg/5 mL oral suspension under fasting and non-fasting conditions, and NCT00834132 and NCT00834756 study 600 mg tablets under fed and fasting conditions. All trials enrolled healthy adults in the United States.
Zithromax is the brand name for azithromycin, a macrolide antibiotic. The clinical trials for Zithromax evaluate azithromycin oral suspension and tablets for bioavailability in healthy volunteers.