Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting 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: NCT00882700
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

Tracking Information
First Submitted Date  ICMJE April 15, 2009
First Posted Date  ICMJE April 16, 2009
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2009)
Bioequivalence based on AUC and Cmax [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00882700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
Official Title  ICMJE 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 Fasting State
Brief Summary To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
  • Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2009)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 56 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00882700
Other Study ID Numbers  ICMJE 50038
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Larouche, M.D. SFBC Anapharm
PRS Account Sandoz
Verification Date April 2009

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