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

NCT ID: NCT01131949

Last Updated: 2010-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2003-03-31

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 volunteers under fasted conditions.

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lamotrigine (chewable, dispersible)

Lamotrigine Tablets (chewable, dispersible),25 mg of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Lamotrigine

Intervention Type: DRUG

Lamotrigine Tablets (chewable, dispersible), 25 mg

Lamictal

Lamictal Tablets 25 mg of Glaxo SmithKline

Group Type: ACTIVE_COMPARATOR

Lamotrigine

Intervention Type: DRUG

Lamotrigine Tablets (chewable, dispersible), 25 mg

Interventions

Lamotrigine

Lamotrigine Tablets (chewable, dispersible), 25 mg

Intervention Type: DRUG

Other Intervention Names

Lamictal

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Ralph Scallion E.E, M.D.

Role: PRINCIPAL_INVESTIGATOR

AAIPharma

Locations

AAI Clinic

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

AAI-US-147

Identifier Type: -

Identifier Source: org_study_id