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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00882154
First received: April 14, 2009
Last updated: April 15, 2009
Last verified: April 2009

April 14, 2009
April 15, 2009
April 2005
April 2005   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00882154 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
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

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
  • Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
  • Experimental: 1
    Cefdinir 300 mg Capsule (Sandoz, Austria)
    Intervention: Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
  • Active Comparator: 2
    Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
    Intervention: Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2005
April 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 56 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00882154
50039
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Richard Larouche, M.D. SFBC Anapharm
Sandoz
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP