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

NCT00745264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • IDEA AG

    lead INDUSTRY

Principal Investigators

  • Egbert Seidel, MD, PhD · X-pert Med GmbH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-03-31
Completion
2008-05-31

Countries

  • Germany

Study Locations

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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 NCT00745264 on ClinicalTrials.gov