Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

NCT ID: NCT00934921

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2003-02-28

Brief Summary

The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking, adult subjects.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ondansetron

Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

1 x 8 mg Orally Disintegrating Tablet

Zofran®

Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

Zofran®

Intervention Type: DRUG

1 x 8 mg ODT

Interventions

Ondansetron

1 x 8 mg Orally Disintegrating Tablet

Intervention Type: DRUG

Zofran®

1 x 8 mg ODT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All subjects selected for this study will be non-smokers at least 18 years of age.
• Subjects will have a BMI (body mass index) of 30 or less.

Exclusion Criteria

• Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
• Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
• Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
• Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
• All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
• Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
• Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
• Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
• All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
• Subjects who do not tolerate venipuncture will not be allowed to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Solomon G Ghide, MD

Role: PRINCIPAL_INVESTIGATOR

Novum

Locations

Novum Pharmaceutical Research Services

Houston, Texas, United States

Countries

United States

Other Identifiers

B026528

Identifier Type: -

Identifier Source: org_study_id