Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

• ClinicalTrials.gov Identifier: NCT00653458
• Recruitment Status: Completed
• First Posted: April 7, 2008
• Last Update Posted: April 11, 2008
• Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Algorithme Pharma Inc
• Information provided by: Par Pharmaceutical, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Ondansetron; Drug: Zofran	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: August 2002
• Actual Primary Completion Date: September 2002
• Actual Study Completion Date: September 2002

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Subjects received Kali formulated products under fed conditions	Drug: Ondansetron; ODT, 8 mg, single-dose, fed conditions; Other Name: 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 Name: Ondansetron ODT

Outcome Measures

Primary Outcome Measures :

1. Rate and Extend of Absorption [ Time Frame: 24 Hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Algorithme Pharma Inc

Investigators

• Principal Investigator: Christian Aumais; Algotithme Pharma Inc

More Information

• Responsible Party: Dr.Alfred Elvin/ Diector Biopharmaceutics, Par Pharmaceutical, Inc.
• ClinicalTrials.gov Identifier: NCT00653458
• Other Study ID Numbers: ODO-P2-159
• First Posted: April 7, 2008
• Last Update Posted: April 11, 2008
• Last Verified: April 2008

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence; Ondansetron ODT; fed; To determine bioequivalence under fed conditions

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders; Ondansetron; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; 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