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Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00650208
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008

March 30, 2008
March 31, 2008
July 2004
August 2004   (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 NCT00650208 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
Single-Dose Fasting In Vivo Bioequivalence Study of Lamotrigine Tablets (25 mg; Mylan) to Lamictal® Tablets (25 mg; GSK) in Healthy Volunteers

The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Lamotrigine Tablets 25 mg
    2x25mg, single dose fasting
  • Drug: Lamictal® Tablets 25 mg
    2x25mg, single dose fasting
  • Experimental: 1
    Lamotrigine Tablets 25 mg
    Intervention: Drug: Lamotrigine Tablets 25 mg
  • Active Comparator: 2
    Lamictal® Tablets 25 mg
    Intervention: Drug: Lamictal® Tablets 25 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

    1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (-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 (-HCG) pregnancy test will be performed upon completion of the study.
    2. Women must practice abstinence or be using an acceptable form of contraception throughout the study. No hormonal contraceptives or hormonal replacement therapies 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,
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. surgical sterilization
    3. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:

      1. postmenopausal with an absence of menses for at least one (1) year, or
      2. bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
      3. total hysterectomy
    4. 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. Males must also use a spermicide containing barrier method of contraception to prevent the pregnancy of their sexual partners. These stipulations should be documented in the informed consent form.
  3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects 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, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate, 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 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. A positive test for any drug included in the urine drug screen.
    6. History of drug and/or alcohol abuse.
  3. Medications:

    1. Use of any prescription or over-the-counter (OTC) medications within 14 days prior to the initial dose of study medication.
    2. Use of any hormonal contraceptives and hormone replacement therapy within 3 months prior to study medication dosing.
    3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
    2. Acute illness at the time of either the pre-study medical evaluation or dosing.
    3. A 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 (> 450 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 lamotrigine or any other related products.
  9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or any 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
 
NCT00650208
LAMO-0445
Not Provided
Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Dorian Williams, 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