Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

Par Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Zofran

Drug: Ondansetron

Study type

Interventional

Funder types

Industry

Identifiers

NCT00653458

ODO-P2-159

Details and patient eligibility

About

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

Full 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

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.