Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

Mental Disorders Clinical Trial

Official title:

An Open-label, Randomised, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Characteristics, Safety and Tolerability of up to Two Formulations (With Different Taste Masking Approaches) of an Orally Disintegrating Tablet (ODT) of Lamotrigine at 25mg and 200mg Versus the Immediate Release (IR) Lamotrigine in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410371
• Other study ID #: LBI108614
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2006
• Last updated: September 11, 2017
• Start date: December 28, 2006
• Est. completion date: January 25, 2007

Study information

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

Clinical Trial Summary

This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 25, 2007
• Est. primary completion date: January 25, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.

Exclusion Criteria:

• Female subjects of childbearing potential will not be eligible to participate 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 (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) 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

• Current smokers of 10 or more cigarettes per day

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Lamotrigine
Lamotrigine
• GI267119
25 mg ODT

Locations

Country	Name	City	State
United States	GSK Investigational Site	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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
Secondary	tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points		throughout study

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 LBI108614 can be found on the GSK Clinical Study Register.