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

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ClinicalTrials.gov Identifier: NCT00946387
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions
Study Start Date : September 2004
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ]


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Ages Eligible for Study:   22 Years to 58 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): NCT00946387


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946387     History of Changes
Other Study ID Numbers: B043712
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Antiemetic

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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