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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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Lamotrigine
Drug: Lamictal®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 Fed Condition.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2002
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01513681

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

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01513681     History of Changes
Other Study ID Numbers: AAI-US-136
Study First Received: January 17, 2012
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Lamotrigine
crossover

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 November 25, 2014