Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ondansetron; Drug: Zofran

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Subjects received Kali formulated products under fed conditions	Drug: Ondansetron; ODT, 8 mg, single-dose, fed conditions; Other Names: Zofran ODT
Active Comparator: B; Subjects received GlaxoSmithKline's formulated products under fed conditions	Drug: Zofran; ODT, 8 mg, single-dose, under fed conditions; Other Names: Ondansetron ODT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	24 Hours

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Algorithme Pharma Inc
• Investigators: Principal Investigator: Christian Aumais, Algotithme Pharma Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): September 1, 2002

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Estimate): April 11, 2008
• Last Update Submitted That Met QC Criteria: April 10, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: bioequivalence; fed; Ondansetron ODT; To determine bioequivalence under fed conditions
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: ODO-P2-159