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

Overview[ - collapse ][ - ]

Purpose 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 fed conditions.
ConditionHealthy
InterventionDrug: Lamotrigine Tablets 25 mg
Drug: Lamictal® Tablets 25 mg
PhasePhase 1
SponsorMylan Pharmaceuticals
Responsible PartyMylan Pharmaceuticals
ClinicalTrials.gov IdentifierNCT00647751
First ReceivedMarch 30, 2008
Last UpdatedMarch 31, 2008
Last verifiedMarch 2008

Tracking Information[ + expand ][ + ]

First Received DateMarch 30, 2008
Last Updated DateMarch 31, 2008
Start DateAugust 2004
Estimated Primary Completion DateAugust 2004
Current Primary Outcome MeasuresBioequivalence [Time Frame: within 30 days] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleFood Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
Official TitleSingle-Dose Food In Vivo Bioequivalence Study of Lamotrigine Tablets (25 mg; Mylan) to Lamictal® Tablets (25 mg; GSK) in Healthy Volunteers
Brief Summary
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 fed conditions.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy
InterventionDrug: Lamotrigine Tablets 25 mg
2x25mg, single dose fed
Drug: Lamictal® Tablets 25 mg
2x25mg, single dose fed
Study Arm (s)
  • Experimental: 1
    Lamotrigine Tablets 25 mg
  • Active Comparator: 2
    Lamictal® Tablets 25 mg

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment28
Estimated Completion DateAugust 2004
Estimated Primary Completion DateAugust 2004
Eligibility Criteria
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00647751
Other Study ID NumbersLAMO-0446
Has Data Monitoring CommitteeNot Provided
Information Provided ByMylan Pharmaceuticals
Study SponsorMylan Pharmaceuticals
CollaboratorsNot Provided
Investigators Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
Verification DateMarch 2008

Locations[ + expand ][ + ]

Kendle International Inc.
Morgantown, West Virginia, United States, 26505