To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00946387

First received: July 24, 2009

Last updated: NA

Last verified: July 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 24, 2009

Last Updated Date

July 24, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence based on AUC and Cmax [ Time Frame: 9 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 Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

Official Title ^ICMJE

A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

Brief Summary

To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Nausea
Vomiting

Intervention ^ICMJE

Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Study Arm (s)

Experimental: 1
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)

Intervention: Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Active Comparator: 2
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Intervention: Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

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

September 2004

Primary Completion Date

September 2004 (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

22 Years to 58 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

NCT00946387

Other Study ID Numbers ^ICMJE

B043712

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:

Soran Hong, M.D.

Novum Pharmaceutical Research Services

Information Provided By

Sandoz

Verification Date

July 2009

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

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