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

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ClinicalTrials.gov Identifier: NCT00882570
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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 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 Fasting State
Study Start Date : April 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
Active Comparator: 2
Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ]


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.

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): NCT00882570


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00882570     History of Changes
Other Study ID Numbers: 50040
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