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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00947128
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Nausea
Vomiting
 Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: September 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
 Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Active Comparator: 2
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
 Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

  Eligibility

Ages Eligible for Study:   20 Years to 58 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947128

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Soran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00947128     History of Changes
Other Study ID Numbers: B043713
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antiemetic

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 16, 2013