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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00883883
First received: April 16, 2009
Last updated: April 17, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott 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 Fed State

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 15 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 Suspension (Sandoz, Austria)
Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
Active Comparator: 2
Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)
Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883883

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00883883     History of Changes
Other Study ID Numbers: 50041
Study First Received: April 16, 2009
Last Updated: April 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antibiotic

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

ClinicalTrials.gov processed this record on August 28, 2014