To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00882570
First received: April 15, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.


Condition Intervention Phase
Healthy
Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fasting State

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
Active Comparator: 2
Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)

  Eligibility

Ages Eligible for Study:   18 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00882570

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Richard Larouche, M.D. SFBC Anapharm
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00882570     History of Changes
Other Study ID Numbers: 50040
Study First Received: April 15, 2009
Last Updated: April 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antibiotic

Additional relevant MeSH terms:
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014