Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions - Full Text View

Sponsor:	Par Pharmaceutical, Inc.
Collaborator:	Algorithme Pharma Inc
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00659074

Purpose

Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT

Condition	Intervention	Phase
Healthy	Drug: Ondansetron Drug: Zofran	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Factorial Assignment
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

Resource links provided by NLM:

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and Extend of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	October 2003
Study Completion Date:	February 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Ondansetron ODT	Drug: Ondansetron ODT, single-dose, fasting
B: Active Comparator Zofran ODT	Drug: Zofran ODT, single-dose, fasting

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659074

Locations

Canada, Quebec
Algorithme Pharma
Laval, Quebec, Canada, H7V 4B4

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Algorithme Pharma Inc

Investigators

Principal Investigator:

Eric Sicard

Algotithme Pharma Inc

More Information

No publications provided

Responsible Party:	Par Pharmaceutical, Inc. ( Dr. Alfed Elvin/ Director Biopharmaceutics )
Study ID Numbers:	ODO-P3-266
Study First Received:	April 10, 2008
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00659074 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence
Ondansetron ODT
Fasting
To Determine Bioequivalence Under Fasting Conditions

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Ondansetron
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010