drugset / Trial / NCT00989625

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

NCT00989625

Phase 1 Completed 50 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naproxen Small molecule 60 mg
Comparator Naproxen Small molecule 180 mg
Comparator Naproxen Small molecule 500 mg
Comparator Sumatriptan Unknown 10 mg
Comparator Sumatriptan Unknown 30 mg
Comparator Sumatriptan Unknown 85 mg

Indications