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

NCT ID: NCT00659685

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Healthy

Keywords

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Bioequivalence Ondansetron ODT Fasting To Determine Bioequivalence Under Fasting conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

Subjects received Kali formulated products under fasting conditions

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

ODT, single-dose, fasting

B

Subjects received GlaxoSmithKline formulated products under fasting conditions

Group Type ACTIVE_COMPARATOR

Zofran ODT

Intervention Type DRUG

Interventions

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Ondansetron

ODT, single-dose, fasting

Intervention Type DRUG

Zofran ODT

Intervention Type DRUG

Other Intervention Names

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Zofran ODT Ondansetron ODT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Algorithme Pharma Inc

INDUSTRY

Sponsor Role collaborator

Par Pharmaceutical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Par Pharmaceutical, Inc.

Principal Investigators

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Christian Aumais

Role: PRINCIPAL_INVESTIGATOR

Algotithme Pharma Inc

Locations

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Algorithme Pharma

Laval, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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ODO-P3-265

Identifier Type: -

Identifier Source: org_study_id