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Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00653458
First received: April 4, 2008
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  Purpose

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


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

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

Resource links provided by NLM:

U.S. FDA Resources

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: 18
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 fed conditions
 Drug: Ondansetron
ODT, 8 mg, single-dose, fed conditions
Other Name: Zofran ODT
Active Comparator: B
Subjects received GlaxoSmithKline's formulated products under fed conditions
 Drug: Zofran
ODT, 8 mg, single-dose, under fed conditions
Other Name: Ondansetron ODT

Detailed Description:

To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed 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 from duly signed by the subject.
  • Males and females aged from 18 to 50 years 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 ant 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 the 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 other 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 pregnant, lactating or are likely to become pregnant during the study phases.
  • Females or childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study.
  • Positive pregnancy test before and during the study.
  • Maintenance therapy with any drug, or significant history of drug dependency, 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 day 1 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 screenings 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653458

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/ Diector Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00653458     History of Changes
Other Study ID Numbers: ODO-P2-159
Study First Received: April 4, 2008
Last Updated: April 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
Ondansetron ODT
fed
To determine bioequivalence under fed 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 May 19, 2013