Bioavailability Study of Ondansetron 16 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:	NCT00659685

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: 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

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:	November 2003

Arms	Assigned Interventions
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

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

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 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

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

No publications provided

Responsible Party:	Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00659685 History of Changes
Other Study ID Numbers:	ODO-P3-265
Study First Received:	April 10, 2008
Last Updated:	April 15, 2008
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:

Disease
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on February 09, 2012