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Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00659074
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 24 mg oDT and Zofran 24 mg ODT

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

Detailed Description:
To Compare the single-dose bioavailability of Kali's Ondansetron 24 mg ODT with that of GlaxoSmithKine's Zofran 24 mg ODT under fasting conditions

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 24 mg ODT With That of GlaxoSmithKine's Zofran 24 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions
Study Start Date : October 2003
Primary Completion Date : January 2004
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Ondansetron ODT
Drug: Ondansetron
ODT, single-dose, fasting
Other Name: Zofran ODT
Active Comparator: B
Zofran ODT
Drug: Zofran
ODT, single-dose, fasting
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 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), or serious psychological disease.
  • 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 7.1.4).
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00659074

Canada, Quebec
Algorithme Pharma
Laval, Quebec, Canada, H7V 4B4
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
Principal Investigator: Eric Sicard Algotithme Pharma Inc

Responsible Party: Dr. Alfed Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00659074     History of Changes
Other Study ID Numbers: ODO-P3-266
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:
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