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Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed 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: NCT00653458
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : April 11, 2008
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.

Brief Summary:
To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg

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 ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed conditions

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability Study of Kali's Ondansetron ODT 8 mg With That of GlaxoSmithKine's Zofran ODT 8 mg in Healthy Adult Subjects Under Fed Conditions
Study Start Date : August 2002
Actual Primary Completion Date : September 2002
Actual Study Completion Date : September 2002

Arm Intervention/treatment
Experimental: A
Subjects received Kali formulated products under fed conditions
Drug: Ondansetron
ODT, 8 mg, single-dose, fed conditions
Other Name: Zofran ODT

Active Comparator: B
Subjects received GlaxoSmithKline's formulated products under fed conditions
Drug: Zofran
ODT, 8 mg, single-dose, under fed conditions
Other Name: Ondansetron ODT

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects meeting all of the following criteria may be included in the study
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent from duly signed by the subject.
  • Males and females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without ant clinical significance and must be recorded as such in the CRF ( laboratory tests are presented in section 7.1.3)
  • Healthy according to the laboratory results and physical examination.
  • Normal cardiovascular function according to the to ECG.
  • 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 other 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 pregnant, lactating or are likely to become pregnant during the study phases.
  • Females or childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study.
  • Positive pregnancy test before and during the study.
  • Maintenance therapy with any drug, or significant history of drug dependency, 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 day 1 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 screenings of drugs of abuse (drug names are presented in section 7.1.4).
  • Positive results to HIV, HBsAg or anti-HCV tests.
  • History of fainting upon blood sampling.

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): NCT00653458

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/ Diector Biopharmaceutics, Par Pharmaceutical, Inc. Identifier: NCT00653458    
Other Study ID Numbers: ODO-P2-159
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008
Keywords provided by Par Pharmaceutical, Inc.:
Ondansetron ODT
To determine bioequivalence under fed conditions
Additional relevant MeSH terms:
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Nutrition Disorders
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