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A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.

NCT00989625 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-06-19

No results posted yet for this study

Summary

This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters will be compared between these two groups and between doses.

Conditions

  • Migraine Disorders

Interventions

DRUG

This is a pharmacokinetic study (Treximet)

This is a pharmacokinetic study to collect PK samples from subject after single dose.

DRUG

This is a pharmacokinetic study (Treximet)

This is a pharmacokinetic study to collect PK samples from subject after single dose.

DRUG

This is a pharmacokinetic study (Treximet)

This is a pharmacokinetic study to collect PK samples from subject after single dose.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-04
Primary Completion
2009-09-10
Completion
2009-09-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989625 on ClinicalTrials.gov