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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01131975
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Healthy
Drug: Lamotrigine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
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 Fed 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 ] [ Designated as safety issue: No ]

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131975

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

No publications provided

Responsible Party: M.S. Mohan / Senior Manager, R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01131975     History of Changes
Other Study ID Numbers: AAI-US-148
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anticonvulsants
Lamotrigine
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014