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Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting Condition

This study has been completed.
Information provided by:
Dr. Reddy's Laboratories Limited Identifier:
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
The purpose of this study is to determine the pharmacokinetics and bioequivalence of lamotrigine formulations after administration of single doses to non-smoking, healthy volunteers under fasted conditions.

Condition Intervention Phase
Healthy Drug: Lamotrigine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: 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 Fasting Condition

Resource links provided by NLM:

Further study details as provided by Dr. Reddy's Laboratories Limited:

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

Enrollment: 26
Study Start Date: January 2003
Study Completion Date: March 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
A single-dose, two-way, bioequivalence study in up to 26 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fasted conditions.

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.
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Please refer to this study by its identifier: NCT01131949

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

Responsible Party: Senior Manager, R&D, Dr. Reddy's Laboratories Limited Identifier: NCT01131949     History of Changes
Other Study ID Numbers: AAI-US-147
Study First Received: May 26, 2010
Last Updated: June 11, 2010

Keywords provided by Dr. Reddy's Laboratories Limited:
Lamotrigine (chewable, dispersible)

Additional relevant MeSH terms:
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on June 23, 2017