Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions - Full Text View

Sponsors and Collaborators:	Par Pharmaceutical, Inc. Algorithme Pharma Inc
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00653458

Purpose

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

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

Drug Information available for: Ondansetron Ondansetron hydrochloride

U.S. FDA Resources

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

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:	18
Study Start Date:	August 2002
Study Completion Date:	September 2002
Primary Completion Date:	September 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Subjects received Kali formulated products under fed conditions	Drug: Ondansetron ODT, 8 mg, single-dose, fed conditions
B: Active Comparator Subjects received GlaxoSmithKline's formulated products under fed conditions	Drug: Zofran ODT, 8 mg, single-dose, under fed conditions

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653458

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Algorithme Pharma Inc

Investigators

Principal Investigator:

Christian Aumais

Algotithme Pharma Inc

More Information

Responsible Party:	Par Pharmaceutical, Inc. ( Dr.Alfred Elvin/ Diector Biopharmaceutics )
Study ID Numbers:	ODO-P2-159
Study First Received:	April 4, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00653458
Health Authority:	United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence
Ondansetron ODT
fed
To determine bioequivalence under fed conditions

Study placed in the following topic categories:

Malnutrition
Ondansetron
Healthy
Serotonin

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
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009