Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting
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.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Cefdinir for oral suspension 250 mg/5mL, OMNICEF® for oral suspension 250 mg/5mL
Novum Pharmaceutical Research Services
Teva Pharmaceuticals USA
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00835549
- Information obtained from ClinicalTrials.gov on July 15, 2010
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Medical and Biotech [MESH] Definitions
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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.
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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.