Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting

21:16 EDT 30th June 2015 | BioPortfolio

Summary

The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under non-fasting conditions.

Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

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

Conditions

Healthy

Intervention

Cefdinir for oral suspension 250 mg/5mL, OMNICEF® for oral suspension 250 mg/5mL

Location

Novum Pharmaceutical Research Services
Houston
Texas
United States
77042

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

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