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

09:35 EDT 16th April 2014 | 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

Medical and Biotech [MESH] Definitions

A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)

The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.

Disorders of the mouth attendant upon non-oral disease or injury.

A dental specialty concerned with the diagnosis and surgical treatment of disease, injuries, and defects of the human oral and maxillofacial region.

An offensive, foul breath odor resulting from a variety of causes such as poor oral hygiene, dental or oral infections, or the ingestion of certain foods.

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