Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01513681
First received: January 17, 2012
Last updated: NA
Last verified: October 2002
History: No changes posted

January 17, 2012
January 17, 2012
November 2002
November 2002   (final data collection date for primary outcome measure)
Area 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition.

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Lamotrigine
    Lamotrigine Tablets 200 mg
    Other Name: Lamictal® 200 mg
  • Drug: Lamictal®
    Lamictal® 200 mg Tablets
  • Experimental: Lamotrigine Tablets 200 mg
    Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
    Interventions:
    • Drug: Lamotrigine
    • Drug: Lamictal®
  • Active Comparator: Lamictal® 200 mg Tablets
    Lamictal® 200 mg Tablets of GlaxoSmithKline Inc
    Interventions:
    • Drug: Lamotrigine
    • Drug: Lamictal®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2002
November 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01513681
AAI-US-136
No
Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Dr. Ralph Scallion, MD AAI Clinic
Dr. Reddy's Laboratories Limited
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP