NCT00745264

Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise

Multi-Centre, Open-Label, Two Segment, Parallel Group Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: IDEA AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

* Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to * 400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure) * 100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application * 100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	Diractin	100 mg Ketoprofen to 2 joints
DRUG	Diractin	400 mg ketoprofen to 4 joints
DRUG	Diractin	100 and 400 mg Ketoprofen used concomittant with heat
DRUG	Diractin	100 and 400 mg Ketoprofen concomittant with moderate exercise

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-03-01
• Completion: 2008-05-01
• First posted: 2008-09-03
• Last updated: 2009-03-20

Locations

2 sites across 1 country: Germany