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

NCT00659685 | Completed Phase 1

• 1 other identifier: ODO-P3-265
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 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 GlaxoSmithKline formulated products under fasting conditions

Drug: Zofran ODT

Interventions

Ondansetron DRUG

ODT, single-dose, fasting

Also known as: Zofran ODT

A

Zofran ODT DRUG

Also known as: Ondansetron ODT

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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.

Sponsors & Collaborators

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

Study Sites (1)

Algorithme Pharma

Laval, Quebec, H4N 2Y8, Canada

Location

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 10, 2008
• First Posted: April 16, 2008
• Study Start: November 1, 2003
• Last Updated: April 16, 2008

Record last verified: 2008-03

Locations

CA (1)