NCT00989625

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

An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be an open label, single dose, randomised, parallel group study. Approximately 27 adolescent patients with migraine and 27 healthy volunteer (HV) adult subjects will be enrolled so that a total of 24 evaluable subjects complete in each group. The treatment procedures for these two groups are almost identical but some flexibility has been allowed for the timing of some of the PK samples in adolescents. All subjects will be required to attend a screening visit within 28 days prior to the first dose of study medication. Each subject will participate in one dosing session with one of the 3 doses of sumatriptan/ naproxen sodium. Sequential PK samples will be collected through 48 hours after dosing and the PK parameters will be compared between these two groups and between doses.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-04
• Primary completion: 2009-09-10
• Completion: 2009-09-10
• First posted: 2009-10-05
• Last updated: 2017-06-19

Locations

3 sites across 1 country: United States