Overview

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

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
Summary
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborator:
Algorithme Pharma Inc
Treatments:
Ondansetron
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.