Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions

Condition(s) targeted: Healthy

Intervention: Ondansetron (Drug); Zofran (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Eric Sicard, Principal Investigator, Affiliation: Algotithme Pharma Inc

Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT

Official title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 24 mg ODT With That of GlaxoSmithKine's Zofran 24 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Primary outcome: Rate and Extend of Absorption

Detailed description: To Compare the single-dose bioavailability of Kali's Ondansetron 24 mg ODT with that of GlaxoSmithKine's Zofran 24 mg ODT under fasting conditions

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Availability of subject for the entire study period and willingness to adhere to

protocol requirements as evidenced by the informed consent form(ICF) duly signed by the volunteer

- Males and females aged between 18 and 55 years with a body mass index (BMI) greater

or equal to 19 and below 30 kg/ m2

- Clinical laboratory values within the laboratory's stated normal range; if not within

this range, they must be without any clinical significance(laboratory tests are presented in section 6. 1.1. 3)

- Healthy according to the laboratory results and physical examination.

- 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.

Algorithme Pharma, Laval, Quebec H7V 4B4, Canada

Starting date: October 2003
Last updated: April 15, 2008