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

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ClinicalTrials.gov Identifier: NCT00659685
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


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

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

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 6.1.1.3)
  • 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 6.1.1.4).
  • Positive results to HIV, HBsAg or anti-HCV tests.
Contacts and Locations
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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): NCT00659685


Locations
Canada, Quebec
Algorithme Pharma
Laval, Quebec, Canada, H4N 2Y8
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
Investigators
Principal Investigator: Christian Aumais Algotithme Pharma Inc
More Information
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Responsible Party: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00659685     History of Changes
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.:
Bioequivalence
Ondansetron ODT
Fasting
To Determine Bioequivalence Under Fasting conditions

Additional relevant MeSH terms:
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