Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

NCT00653458 | Completed Phase 1

• 1 other identifier: ODO-P2-159
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 Hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received Kali formulated products under fed conditions

Drug: Ondansetron

B

ACTIVE COMPARATOR

Subjects received GlaxoSmithKline's formulated products under fed conditions

Drug: Zofran

Interventions

Ondansetron DRUG

ODT, 8 mg, single-dose, fed conditions

Also known as: Zofran ODT

A

Zofran DRUG

ODT, 8 mg, single-dose, under fed conditions

Also known as: Ondansetron ODT

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Algorithme Pharma Inc: collaborator

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Christian Aumais

  Algotithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 7, 2008
• Study Start: August 1, 2002
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: April 11, 2008

Record last verified: 2008-04