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To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

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.
ClinicalTrials.gov Identifier: NCT00882154
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cefdinir 300 mg Capsule (Sandoz, Austria) Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State
Study Start Date : April 2005
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Cefdinir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Cefdinir 300 mg Capsule (Sandoz, Austria)
Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
Active Comparator: 2
Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 7 days ]

Eligibility Criteria

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): NCT00882154


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00882154     History of Changes
Other Study ID Numbers: 50039
First Posted: April 16, 2009    Key Record Dates
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