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Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659685
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.

Brief Summary:
Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg ODT

Condition or disease Intervention/treatment Phase
Healthy Drug: Ondansetron Drug: Zofran ODT Phase 1

Detailed Description:
To Compare the single-dose bioavailability of Kali's Ondansetron 16 mg ODT with that of GlaxoSmithKine's Zofran 16 mg ODT under fasting conditions

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 16 mg ODT With That of GlaxoSmithKine's Zofran 16 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions
Study Start Date : November 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Subjects received Kali formulated products under fasting conditions
Drug: Ondansetron
ODT, single-dose, fasting
Other Name: Zofran ODT

Active Comparator: B
Subjects received GlaxoSmithKline formulated products under fasting conditions
Drug: Zofran ODT
Other Name: Ondansetron ODT

Primary Outcome Measures :
  1. Rate and Extend of absorption [ Time Frame: 24 Hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(ICF) duly signed by the volunteer
  • Males and females aged between 18 and 55 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/ m2
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section
  • Healthy according to the laboratory results and physical examination.
  • Non- or ex- smokers

Exclusion Criteria:

  • Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
  • Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
  • Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
  • Females who are pregnant, lactating or are likely to become pregnant during the study phases.
  • Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body.
  • Positive serum pregnancy test before and during the study.
  • Maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
  • Any clinically significant illness in the previous 28 days before day 1 of this study.
  • Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
  • Participation in another clinical trial in the previous 28 days before day 1 of this study.
  • Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
  • Positive urine screening of drugs of abuse (drug names are presented in section
  • Positive results to HIV, HBsAg or anti-HCV tests.

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 identifier (NCT number): NCT00659685

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Canada, Quebec
Algorithme Pharma
Laval, Quebec, Canada, H4N 2Y8
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
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Principal Investigator: Christian Aumais Algotithme Pharma Inc

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Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc. Identifier: NCT00659685    
Other Study ID Numbers: ODO-P3-265
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: March 2008
Keywords provided by Par Pharmaceutical, Inc.:
Ondansetron ODT
To Determine Bioequivalence Under Fasting conditions
Additional relevant MeSH terms:
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Pathologic Processes
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