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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2004-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00650208

Healthy

COMPLETED PHASE1

Lamotrigine 25 mg Chewable Tablets, Fasting

NCT00838279

Healthy

COMPLETED PHASE1

Lamotrigine 25 mg Chewable Tablets, Non-Fasting

NCT00838136

Healthy

COMPLETED PHASE1

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

NCT01131975

Healthy

COMPLETED PHASE1

A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions

NCT03898011

Healthy Adults

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Lamotrigine Tablets 25 mg

Group Type EXPERIMENTAL

Lamotrigine Tablets 25 mg

Intervention Type DRUG

2x25mg, single dose fed

2

Lamictal® Tablets 25 mg

Group Type ACTIVE_COMPARATOR

Lamictal® Tablets 25 mg

Intervention Type DRUG

2x25mg, single dose fed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lamotrigine Tablets 25 mg

2x25mg, single dose fed

Intervention Type DRUG

Lamictal® Tablets 25 mg

2x25mg, single dose fed

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes