Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: Lamotrigine

• Registration Number: NCT00412191
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Study Start: 2007-02-06
• Primary Completion: 2007-04-27
• Study Completion: 2007-04-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 - 29.9 kg/m2 inclusive.
• Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.

Read More

Exclusion Criteria

• Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest.
• Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
• Female subjects using hormonal contraceptive precautions including progesterone-coated IUD
• Female subjects using hormonal replacement therapy.
• Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed).
• Current smokers of 10 or more cigarettes per day.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects in treatment regimen B	Lamotrigine	Subjects in treatment regimen B will receive 100 mg lamotrigine XR in fasting condition.
Subjects in treatment regimen A	Lamotrigine	Subjects in treatment regimen A will receive 100 and 200 mg lamotrigine XR in fasting condition.
Subjects in treatment regimen C	Lamotrigine	Subjects in treatment regimen C will receive 100 mg lamotrigine XR in fed condition.

Primary Outcome Measures

Name	Time	Method
pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf)	taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing

Secondary Outcome Measures

Name	Time	Method
PK (AUC (0-t), tmax and t1/2 )	taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing
safety and tolerability based on physical exam, adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate measure	at Screening, Day -1, Day 1, Day 2 and follow up 7-14 days after dosing

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany