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