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Zithromax · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Azithromycin Tablets 600 mg |
| 2 | ACTIVE_COMPARATOR | Zithromax® Tablets 600 mg |
| Name | Type | Description |
|---|---|---|
| Azithromycin Tablets 600 mg | DRUG | 600mg, single dose fed |
| Zithromax® Tablets 600 mg | DRUG | 600mg, single dose fed |
Inclusion Criteria: * 1\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ...
Zithromax is being studied in healthy volunteers in Phase 1 clinical trials to evaluate the pharmacokinetics of azithromycin tablets. These trials are not for treating a disease but rather to assess how the drug is absorbed and processed in the body, specifically comparing a 600 mg tablet formulation to the reference product.
Zithromax is a small molecule antibiotic that targets bacterial infections. It works by inhibiting bacterial protein synthesis, specifically binding to the 50S ribosomal subunit, which prevents bacteria from growing and multiplying. This mechanism is effective against a range of susceptible bacteria, though the current trials focus on healthy volunteers.
Zithromax is developed by Viatris Inc., a global healthcare company. Viatris is responsible for the clinical development and commercialization of the drug. The company is publicly traded on the NASDAQ under the ticker symbol VTRS.
Zithromax is in Phase 1 clinical development. The current trials are early-stage studies designed to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers. These are not late-stage efficacy trials, and the drug is not yet approved for any new indication based on these studies.
Zithromax has two completed Phase 1 clinical trials: NCT00649935, a fed study comparing azithromycin tablets 600 mg to Zithromax tablets 600 mg, and NCT00650273, a fasting study with the same comparison. Both trials enrolled 54 healthy volunteers each in the United States, with a minimum age of 18 years.
Yes, Zithromax is a brand name for azithromycin. The clinical trials listed compare azithromycin tablets to Zithromax tablets, indicating that azithromycin is the active ingredient. Zithromax is the proprietary name used by the developer, Viatris, for this antibiotic.