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

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:

Drug Information available for: Lamotrigine

U.S. FDA Resources

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

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:

Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013