Bioavailability Study of Ondansetron 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:	NCT00654277

Purpose

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

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

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 8 mg ODT With That of GlaxoSmithKine's Zofran 8 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:	32
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 fasting conditions	Drug: Ondansetron ODT, 8 mg, single-dose
B: Active Comparator Subjects received GlaxoSmithKine product under fasting conditions	Drug: Zofran ODT, 8 mg, fasting conditions

Detailed Description:

To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of GlaxoSmithKine's Zofran 8 mg ODT under fasting 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 form duly signed by the subject.
Males and Females aged from 18 to 50 years ol 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 any 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 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 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.
History of fainting upon blood sampling.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654277

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Algorithme Pharma Inc

Investigators

Principal Investigator:

Christian Aumais

Algotithme Pharma Inc

More Information

No publications provided

Responsible Party:	Par Pharmaceutical, Inc. ( Dr. Alfred Elvin/ Director Biopharmacetics )
Study ID Numbers:	ODO-P2-158
Study First Received:	April 3, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00654277 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