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Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects; Mental Disorders

Intervention: Lamotrigine (Drug); GI267119 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

Official title: An Open-label, Randomised, Single-dose, Parallel-group Study to Compare the Pharmacokinetic Characteristics, Safety and Tolerability of Two Formulations of Lamotrigine in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Lamotrigine AUC(0-inf) and Cmax

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

Eligibility

Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

GSK Investigational Site, Lincoln, Nebraska 68502, United States
Additional Information

Starting date: December 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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