Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

Overview[ - collapse ][ - ]

Purpose This is an single dose,two-way, crossover, oral bioequivalence study.
ConditionHealthy
InterventionDrug: Lamotrigine
Drug: Lamictal®
PhasePhase 1
SponsorDr. Reddy's Laboratories Limited
Responsible PartyDr. Reddy's Laboratories Limited
ClinicalTrials.gov IdentifierNCT01513681
First ReceivedJanuary 17, 2012
Last UpdatedJanuary 17, 2012
Last verifiedOctober 2002

Tracking Information[ + expand ][ + ]

First Received DateJanuary 17, 2012
Last Updated DateJanuary 17, 2012
Start DateNovember 2002
Estimated Primary Completion DateNovember 2002
Current Primary Outcome MeasuresArea under curve (AUC) [Time Frame: 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] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleBioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
Official TitleSingle Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition.
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.
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: Lamotrigine
Lamotrigine Tablets 200 mg
Other Names:
Lamictal® 200 mgDrug: Lamictal®
Lamictal® 200 mg Tablets
Study Arm (s)
  • Experimental: Lamotrigine Tablets 200 mg
    Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
  • Active Comparator: Lamictal® 200 mg Tablets
    Lamictal® 200 mg Tablets of GlaxoSmithKline Inc

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment20
Estimated Completion DateNovember 2002
Estimated Primary Completion DateNovember 2002
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01513681
Other Study ID NumbersAAI-US-136
Has Data Monitoring CommitteeNo
Information Provided ByDr. Reddy's Laboratories Limited
Study SponsorDr. Reddy's Laboratories Limited
CollaboratorsNot Provided
Investigators Principal Investigator: Dr. Ralph Scallion, MD AAI Clinic
Verification DateOctober 2002

Locations[ + expand ][ + ]

AAI Clinic
Quadrangle drive, North Carolina, United States, 27514