Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00654277
First received: April 3, 2008
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Ondansetron
Drug: Zofran
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 8 mg ODT With That of GlaxoSmithKine's Zofran 8 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2002
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received Kali formulated products under fasting conditions
Drug: Ondansetron
ODT, 8 mg, single-dose
Other Name: Zofran
Active Comparator: B
Subjects received GlaxoSmithKine product under fasting conditions
Drug: Zofran
ODT, 8 mg, fasting conditions
Other Name: Ondansetron ODT

Detailed Description:

To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of GlaxoSmithKine's Zofran 8 mg ODT under fasting conditions

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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.
  • History of fainting upon blood sampling.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654277

Sponsors and Collaborators
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
Investigators
Principal Investigator: Christian Aumais Algotithme Pharma Inc
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin/ Director Biopharmacetics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00654277     History of Changes
Other Study ID Numbers: ODO-P2-158
Study First Received: April 3, 2008
Last Updated: April 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
Ondansetron ODT
Fasting
To determine bioequivalence under fasting conditions

Additional relevant MeSH terms:
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on September 11, 2014