Clinical trial NCT01513681: Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
Official title: Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Lamotrigine
crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an single dose,two-way, crossover, oral bioequivalence study.

Detailed description: The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

Eligibility criteria: Inclusion Criteria:

1. Healthy males and females at least 18 years of age inclusive
2. Informed of the nature of the study and given written informed consent
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion Criteria:

1. Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion
3. Recent history of mental illness, drug addition,drug abuse or alcoholism
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.
7. Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
8. If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: Pre-dose 0.25, 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Quadrangle drive
country: United States
facility: AAI Clinic
state: North Carolina
Study officials:
affiliation: AAI Clinic
name: Dr. Ralph Scallion, MD
role: PRINCIPAL_INVESTIGATOR
References: