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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.

Condition Intervention Phase
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: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

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: September 2004
Primary Completion Date: September 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)


Ages Eligible for Study:   22 Years to 58 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00946387

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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00946387     History of Changes
Other Study ID Numbers: B043712 
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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 processed this record on October 21, 2016