Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

NCT00412191 | Completed Phase 1

• 1 other identifier: LAM105379
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Keywords

healthy volunteers; bioequivalence; food effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Subjects in treatment regimen A

EXPERIMENTAL

Subjects in treatment regimen A will receive 100 and 200 mg lamotrigine XR in fasting condition.

Drug: Lamotrigine

Subjects in treatment regimen B

EXPERIMENTAL

Subjects in treatment regimen B will receive 100 mg lamotrigine XR in fasting condition.

Drug: Lamotrigine

Subjects in treatment regimen C

EXPERIMENTAL

Subjects in treatment regimen C will receive 100 mg lamotrigine XR in fed condition.

Drug: Lamotrigine

Interventions

Lamotrigine DRUG

In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.

Subjects in treatment regimen A; Subjects in treatment regimen B; Subjects in treatment regimen C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Results for study LAM105379 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 15, 2006
• Study Start: February 6, 2007
• Primary Completion: April 27, 2007
• Study Completion: April 27, 2007
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)