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

2014-08-27 03:24:51 | BioPortfolio

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®.

Description

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Azithromycin, Zithromax®

Location

PRACS Institute, Ltd.
Fargo
North Dakota
United States
58104

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:51-0400

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