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Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
This study has been completed.
Sponsored by: Mylan Pharmaceuticals
Information provided by: Mylan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00649532
  Purpose

The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Ondansetron Tablets 24 mg
Drug: Zofran® Tablets 24 mg
Phase I

Drug Information available for: Ondansetron Ondansetron hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Ondansetron Tablets (24 mg; Mylan) and Zofran® Tablets (24 mg; GSK) in Healthy Volunteers

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2003
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Ondansetron Tablets 24 mg
Drug: Ondansetron Tablets 24 mg
24mg, single dose fasting
2: Active Comparator
Zofran® Tablets 24 mg
Drug: Zofran® Tablets 24 mg
24mg, single dose fasting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18 years and older.
  2. Sex: Male or non-pregnant, non-lactating female

    1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study.
    2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:

      1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. postmenopausal accompanied with a documented postmenopausal course of at least one year, or
      4. surgical sterility (tubal ligation, oophorectomy or hysterectomy).
    3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form.
  3. Weight: At least 60 kg (132 lbs) for males and 48 kg (106 lbs) for females and all subjects within 15% of their Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
  4. All subjects should be judged to be normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Social Habits:

    1. Use of any tobacco products within 1 year of the start of the study.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. Positive test for any drug included in the urine drug screen.
  3. Medications:

    1. Use of any medication within the 14 days prior to the initial dose of study medication. Hormonal contraceptives and hormonal replacement therapy should NOT be used within 3 months of initial study medication.
    2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
    3. Use of any psychotropic agents/drugs within 1 year of the start of the study.
  4. Diseases:

    1. History of any significant chronic disease and/or hepatitis.
    2. History of drug and/or alcohol abuse.
    3. History of ulceration or gastritis considered to be clinically significant.
    4. Acute illness at the time of either the pre-study medical evaluation or dosing.
    5. Positive HIV, Hepatitis B or Hepatitis C test.
  5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  6. Donation or loss of a significant volume of blood or plasma (> 424 mL) within 28 days prior to the initial dose of study medication.
  7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  8. Allergy or hypersensitivity to ondansetron or other selective serotonin receptor antagonist products.
  9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649532

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Walter A Parham, M.D. Cetero Research
  More Information

Mylan Pharmaceuticals Inc. - Clinical Trial Results  This link exits the ClinicalTrials.gov site
Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use  This link exits the ClinicalTrials.gov site
Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
FDA Enforcement Report Index  This link exits the ClinicalTrials.gov site
Medwatch, FDA Safety Information and Adverse Event Reporting Program  This link exits the ClinicalTrials.gov site

Responsible Party: Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management )
Study ID Numbers: ONDA-0313
Study First Received: March 30, 2008
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00649532  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Ondansetron
Healthy
Serotonin

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

ClinicalTrials.gov processed this record on January 15, 2009