A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions

Phase 1 Completed 80 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

Summary

The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.

Timeline

Start: 2005-10
Primary completion: 2005-11
Completion: 2005-11

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 103.08 (90% CI 95.41 to 111.37) NCT00830336 ↗

registry Geometric Test/Ref Ratio x 100 105.84 (90% CI 99.33 to 112.77) NCT00830336 ↗

registry Geometric Test/Ref Ratio x 100 107.04 (90% CI 99.96 to 114.62) NCT00830336 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	400 mg	Oral

Indications

No indication recorded.