NCT00840411

Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Extended Release Tablet Formulation of Clarithromycin (500 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Biaxin® XL Filmtab) in 66 Fasted, Healthy, Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 66 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 ER 500 mg tablets	1 x 500 mg
DRUG	BIAXIN® XL 500 mg tablets	1 x 500 mg

Timeline

• Start date: 2002-09-01
• Primary completion: 2002-10-01
• Completion: 2002-10-01
• First posted: 2009-02-10
• Last updated: 2024-08-19
• Results posted: 2009-07-21

Locations

1 site across 1 country: United States