Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers

Mental Disorders Clinical Trial

Official title:

An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449774
• Other study ID #: LBI108617
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2007
• Last updated: August 5, 2017
• Start date: May 7, 2007
• Est. completion date: June 19, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 19, 2007
• Est. primary completion date: June 19, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female subjects aged 19 to 55 years inclusive

• BMI within the range 19 to 32 kg/m2 inclusive.

Exclusion Criteria:

• Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.

• Female subject is pregnant or lactating.

• Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).

• Female subjects using hormonal replacement therapy.

• History of regular alcohol consumption > 7 drinks week for women and 14 drinks week for men

• Current smokers of 10 or more cigarettes per day

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Lamotrigine IR tablets
Lamotrigine IR tablets will be available in dose strength of 200 mg.
• Lamotrigine ODT tablets
Lamotrigine ODT tablets will be available in dose strength of 200 mg.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours		Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Secondary	Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.		Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study LBI108617 can be found on the GSK Clinical Study Register.