Food Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00647777
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008

March 30, 2008
March 31, 2008
June 2003
July 2003   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647777 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Food Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg
Single-Dose Food In Vivo Bioequivalence Study of Olanzapine Tablets (5 mg; Mylan) and Zyprexa® Tablets (5 mg; Eli Lilly) in Healthy Volunteers

The objective of this study was to investigate the bioequivalence of Mylan olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fed conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Olanzapine Tablets 5 mg
    5mg, single dose fed
  • Drug: Zyprexa® Tablets 5 mg
    5mg, single dose fed
  • Experimental: 1
    Olanzapine Tablets 5 mg
    Intervention: Drug: Olanzapine Tablets 5 mg
  • Active Comparator: 2
    Zyprexa® Tablets 5 mg
    Intervention: Drug: Zyprexa® Tablets 5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2003
July 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

1. Age: 18 years and older. 2. Sex: Male and 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. No hormonal contraceptives or hormonal replacement therapy are permitted in this 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. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
  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 device. This advice should be documented in the informed consent form.

    3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15% of 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 normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, 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.
    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
  3. Medications:

    1. Use of any medication within the 14 days prior to the initial dose of 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 hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant chronic disease and/or hepatitis.
    2. History of drug and/or alcohol abuse.
    3. Acute illness at the time of either the pre-study medical evaluation or dosing.
    4. 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. Sitting heart rate of less than 60 beats per minute and a sitting systolic blood pressure less than 110 or greater than 140 or a sitting diastolic blood pressure less than or greater than 90 after a five-minute resting period at Screening and a sitting heart rate of less than 60 beats per minute and a sitting systolic blood pressure less than 100 or greater than 140 or a sitting diastolic blood pressure less than 60 or greater than 90 after a five-minute resting period just prior to dosing.
  7. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
  8. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  9. Allergy or hypersensitivity to olanzapine, any of the inactive ingredients, or other related products.
  10. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  11. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration"
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00647777
OLAN-0333
Not Provided
Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Thomas S Clark, M.D. Kendle International Inc.
Mylan Pharmaceuticals
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP