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

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00882570

First received: April 15, 2009

Last updated: NA

Last verified: April 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 15, 2009

Last Updated Date

April 15, 2009

Start Date ^ICMJE

April 2005

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)

Study Arm (s)

Experimental: 1
Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)

Intervention: 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)

Intervention: Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot 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

Enrollment ^ICMJE

Completion Date

May 2005

Primary Completion Date

May 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.

Gender

Both

Ages

18 Years to 56 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00882570

Other Study ID Numbers ^ICMJE

50040

Has Data Monitoring Committee

Not Provided

Responsible Party

Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.

Study Sponsor ^ICMJE

Sandoz Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard Larouche, M.D.

SFBC Anapharm

Information Provided By

Sandoz

Verification Date

April 2009

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

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