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Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions

Information source: Par Pharmaceutical, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ondansetron (Drug); Zofran ODT (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

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

Summary

Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg ODT

Clinical Details

Official title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 16 mg ODT With That of GlaxoSmithKine's Zofran 16 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions

Study design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Primary outcome: Rate and Extend of absorption

Detailed description: To Compare the single-dose bioavailability of Kali's Ondansetron 16 mg ODT with that of GlaxoSmithKine's Zofran 16 mg ODT under fasting conditions

Eligibility

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 serum 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).

- 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

6. 1.1. 4).

- Positive results to HIV, HBsAg or anti-HCV tests.

Locations and Contacts

Algorithme Pharma, Laval, Quebec H4N 2Y8, Canada
Additional Information

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

Page last updated: June 20, 2008

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