Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
This study has been completed.
Information provided by (Responsible Party):
First received: March 19, 2007
Last updated: May 31, 2012
Last verified: March 2011
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 Frame: 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 Measures:
- 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. [ Time Frame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above ]
| Study Start Date:
Other Name: Lamotrigine
|Ages Eligible for Study:
||19 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Healthy male or female subjects aged 19 to 55 years inclusive
- BMI within the range 19 to 32 kg/m2 inclusive.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449774
|GSK Investigational Site
|Dallas, Texas, United States, 75247 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 19, 2007
||May 31, 2012
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers