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NCT00605371 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence and Food Effect of 250mg of Lamotrigine XR

A Phase 1 study of Epilepsy, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
209
Enrollment target
1
Study location

NCT00605371 is a Phase 1 study of Epilepsy that has completed, run by GlaxoSmithKline. The registered enrollment target is 209 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00605371, a Phase 1 study of Epilepsy, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
209 participants
Enrollment target
1
Study location

Study Summary

This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers

Conditions Studied

Interventions

  • DRUG Lamotrigine tablet
  • DRUG Lamotrigine caplet

Study Locations (1)

Washington

  • GSK Investigational Site - Tacoma

Trial Details

FieldValue
Enrollment Target 209 participants
Start Date 2008-01-15
Est. Completion 2008-03-06
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00605371

The ClinicalTrials.gov registry entry for NCT00605371 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (78% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Lamotrigine tablet is the first listed.

NCT00605371 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT00605371 about?

NCT00605371 is a clinical study titled "Bioequivalence and Food Effect of 250mg of Lamotrigine XR". This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers

What is the current status of trial NCT00605371?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 209 participants. The study started on 2008-01-15. Estimated completion is 2008-03-06.

What conditions does trial NCT00605371 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT00605371?

The interventions under investigation include: Lamotrigine tablet (DRUG), Lamotrigine caplet (DRUG).

Who is sponsoring clinical trial NCT00605371?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00605371 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.