NCT00834132

Azithromycin 600 Mg Tablets, Fed

A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Azithromycin (600 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Zithromax®, Pfizer, Inc.) in 24 Fed, Healthy, Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in a test population of 24 adult subjects under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Azithromycin 600 mg Tablet	1 x 600mg, single-dose fed
DRUG	Zithromax® 600 mg Tablet	1 x 600mg, single-dose fed

Timeline

• Start date: 2002-07-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States