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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883883
First Posted: April 20, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  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: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883883


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00883883     History of Changes
Other Study ID Numbers: 50041
First Submitted: April 16, 2009
First Posted: April 20, 2009
Last Update Posted: March 29, 2017
Last Verified: April 2009

Keywords provided by Sandoz:
Antibiotic

Additional relevant MeSH terms:
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents