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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: March 27, 2017
Last verified: July 2009
  Purpose
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under 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
Intervention Model: Single Group Assignment
Masking: No masking
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 ]

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)

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946387

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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946387     History of Changes
Other Study ID Numbers: B043712
Study First Received: July 24, 2009
Last Updated: March 27, 2017

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

ClinicalTrials.gov processed this record on July 25, 2017