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Trial record 14 of 215 for:    Lamotrigine

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed 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: NCT01131975
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : June 14, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

Brief Summary:
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

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

Detailed Description:
A single-dose, two-way, bioequivalence study in up to 24 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fed conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Two-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets With Lamictal 25 mg Chewable Tablets in Healthy Volunteers Under Fed Condition
Study Start Date : January 2003
Actual Primary Completion Date : February 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Lamotrigine

Arm Intervention/treatment
Experimental: Lamotrigine (chewable, dispersible)
Lamotrigine Tablets (chewable, dispersible),25 mg of Dr. Reddy's Laboratories Limited
Drug: Lamotrigine
Lamotrigine Tablets (chewable, dispersible), 25 mg
Other Name: Lamictal

Active Comparator: Lamictal
Lamictal Tablets 25 mg of Glaxo SmithKline
Drug: Lamotrigine
Lamotrigine Tablets (chewable, dispersible), 25 mg
Other Name: Lamictal

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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. (Appendix I and II).

Exclusion Criteria:

  • Hypersensitivity to Lamotrigine' (Lamictal®), or similar compounds.
  • Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
  • Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
  • Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or 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-therapeutic indications as judged by the attending physician.
  • Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
  • If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of 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): NCT01131975

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United States, North Carolina
AAI Clinic
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Principal Investigator: Ralph Scallion E.E, M.D. AAIPharma

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Responsible Party: M.S. Mohan / Senior Manager, R&D, Dr. Reddy's Laboratories Limited Identifier: NCT01131975     History of Changes
Other Study ID Numbers: AAI-US-148
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: June 14, 2010
Last Verified: June 2010
Keywords provided by Dr. Reddy's Laboratories Limited:
Lamotrigine (chewable, dispersible)
Additional relevant MeSH terms:
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Nutrition Disorders
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