Status:
COMPLETED
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
20-44 years
Phase:
PHASE1
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 G...
Eligibility Criteria
Inclusion
- Healthy males and females at least 18 years of age inclusive
- Informed of the nature of the study and given written informed consent
- 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
- Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion
- Recent history of mental illness, drug addition,drug abuse or alcoholism
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- 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.
- Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01513720
Start Date
December 1 2002
End Date
December 1 2002
Last Update
January 20 2012
Active Locations (1)
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1
AAI Clinic
Quadrangle Drive, North Carolina, United States, 27514