NCT00650273

Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Azithromycin Tablets (600 mg; Mylan) to Zithromax® Tablets (600 mg; Pfizer) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Azithromycin Tablets 600 mg	600mg, single dose fasting
DRUG	Zithromax® Tablets 600 mg	600mg, single dose fasting

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States