NCT00835692

Clarithromycin 500 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 500 mg Clarithromycin Tablets Under Fasting COnditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects under fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clarithromycin	500 mg Tablet
DRUG	Biaxin®	500 mg Tablet

Timeline

• Start date: 2002-09-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2009-02-04
• Last updated: 2024-08-20
• Results posted: 2009-07-21

Locations

2 sites across 1 country: United States