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

NCT01131949 | Completed Phase 1

• 1 other identifier: AAI-US-147
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Lamotrigine (chewable, dispersible)

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 months

Study Arms (2)

Lamotrigine (chewable, dispersible)

EXPERIMENTAL

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

Drug: Lamotrigine

Lamictal

ACTIVE COMPARATOR

Lamictal Tablets 25 mg of Glaxo SmithKline

Drug: Lamotrigine

Interventions

Lamotrigine DRUG

Lamotrigine Tablets (chewable, dispersible), 25 mg

Also known as: Lamictal

Lamictal; Lamotrigine (chewable, dispersible)

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and II).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

AAI Clinic

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ralph Scallion E.E, M.D.

  AAIPharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: January 1, 2003
• Primary Completion: February 1, 2003
• Study Completion: March 1, 2003
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

US (1)