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
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a to...
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on am...
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Om...
The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals I...
The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250...
No treatment has been approved by the US Food and Drug Administration for eosinophilic esophagitis (EoE). We investigated the efficacy and safety of a new formulation of oral budesonide suspension (OB...
Posaconazole (Noxafil(®)) is a triazole antifungal agent with an extended spectrum of antifungal activity. It is approved for the prophylaxis of invasive fungal infections in patients with neutropeni...
Introduction: Colesevelam HCl (colesevelam) is a bile acid sequestrant initially approved by the US Food and Drug Administration (FDA) in 2000 as an adjunct to diet and exercise to lower elevated low-...
Magnetic suspension systems are mechatronic systems and crucial in several engineering applications, such as the levitation of high-speed trains, frictionless bearings, and wind tunnels. Magnetic susp...
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.