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Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01513720
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Lamotrigine Drug: Lamictal® Phase 1

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 fasting condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fasting Condition.
Study Start Date : December 2002
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
Experimental: Lamotrigine Tablets 200 mg
Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
Drug: Lamotrigine
Lamotrigine Tablets 200 mg
Other Name: Lamictal® 200 mg

Drug: Lamictal®
Lamictal® 200 mg Tablets

Active Comparator: Lamictal® 200 mg Tablets
Lamictal® 200 mg Tablets of GlaxoSmithKline Inc
Drug: Lamotrigine
Lamotrigine Tablets 200 mg
Other Name: Lamictal® 200 mg

Drug: Lamictal®
Lamictal® 200 mg Tablets

Primary Outcome Measures :
  1. Area under curve (AUC) [ Time Frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01513720

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United States, North Carolina
AAI Clinic
Quadrangle drive, North Carolina, United States, 27514
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Principal Investigator: Dr. Ralph Scallion, MD AAI Clinic

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Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT01513720     History of Changes
Other Study ID Numbers: AAI-US-137
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: October 2002
Keywords provided by Dr. Reddy's Laboratories Limited:
Additional relevant MeSH terms:
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Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers