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

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)

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 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

Clinical Details

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

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

Primary outcome: 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 outcome: 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.

Eligibility

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

Criteria:

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

Locations and Contacts

GSK Investigational Site, Dallas, Texas 75247, United States
Additional Information

Starting date: May 2007
Last updated: May 31, 2012

Page last updated: August 23, 2015

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