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

00:03 EDT 27th April 2015 | BioPortfolio


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

Study Design

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
United States




Teva Pharmaceuticals USA

Results (where available)

View Results


Clinical Trials [1767 Associated Clinical Trials listed on BioPortfolio]

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

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...

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

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...

A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications

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...

Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition

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...

Cefprozil for Oral Suspension 250 mg/5 mL, Fasting

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...

PubMed Articles [4370 Associated PubMed Articles listed on BioPortfolio]

Posaconazole: A Review of the Gastro-Resistant Tablet and Intravenous Solution in Invasive Fungal Infections.

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...

Mitek bone-anchored static suture suspension of the oral commissure.

Expanded colesevelam administration options with oral suspension formulation for patients with diabetes and hypercholesterolemia.

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-...

Digital Control Analysis and Design of a Field-Sensed Magnetic Suspension System.

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...

A Practical and Successful Desensitization Protocol for Immediate Hypersensitivity Reactions to Iron Salts.

Orally administered iron salts (OAS) are widely used in the management of iron deficiency anemia and hypersensitivity reactions to OAS are not common. If an offending drug is the sole option or is sig...

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.

More From BioPortfolio on "Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting"

Search BioPortfolio:

Relevant Topic

The Top 100 Pharmaceutical Companies
Latest News Clinical Trials Research Drugs Reports Corporate
Top 100 Pharmaceutical Companies 2012 (SCRIP 100 - http://www.scrip100.com/scrip100.html) Rank (2011 in Brackets) Company SEARCH FOR COMPANY IN BIOPORTFOLIO'S BIOCORPORATE DATABASE 2012 pharma sales...


Searches Linking to this Trial