Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions

NCT00654277 | Completed Phase 1

• 1 other identifier: ODO-P2-158
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT

Conditions

Healthy

Keywords

bioequivalence; Ondansetron ODT; Fasting; To determine bioequivalence under fasting conditions

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 Hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received Kali formulated products under fasting conditions

Drug: Ondansetron

B

ACTIVE COMPARATOR

Subjects received GlaxoSmithKine product under fasting conditions

Drug: Zofran

Interventions

Ondansetron DRUG

ODT, 8 mg, single-dose

Also known as: Zofran

A

Zofran DRUG

ODT, 8 mg, fasting conditions

Also known as: Ondansetron ODT

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects meeting all of the following criteria may be included in the study.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
• Males and Females aged from 18 to 50 years ol with a body mass index (BMI)within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF (laboratory tests are presented in section 7.1.3.
• Healthy according to the laboratory results and physical examination.
• Normal cardiovascular function according to ECG.
• Non or ex-smokers.

You may not qualify if:

• 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.
• History of fainting upon blood sampling.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Algorithme Pharma Inc: collaborator

MeSH Terms

Conditions

Fasting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Christian Aumais

  Algotithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 7, 2008
• Study Start: August 1, 2002
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: April 11, 2008

Record last verified: 2008-04