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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659074

Enrollment

Registered

2008-04-16

Start date

2003-10-31

Completion date

2004-02-29

Last updated

2008-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

bioequivalence, Ondansetron ODT, Fasting, To Determine Bioequivalence Under Fasting Conditions

Brief summary

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

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

Interventions

DRUGOndansetron

ODT, single-dose, fasting

DRUGZofran

ODT, single-dose, fasting

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Rate and Extend of Absorption	24 Hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026