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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745264

Enrollment

Registered

2008-09-03

Start date

2007-10-31

Completion date

2008-05-31

Last updated

2009-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic

Keywords

heat, exercise

Brief 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

Interventions

DRUGDiractin

100 mg Ketoprofen to 2 joints

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* All of the following criteria have to be met to include a subject in the study: * Understands nature and provision of the study * Have been informed about the study by the investigator and gave signed and dated informed consent prior to participation * Male and female subjects * Age 18-55 years * Subjects in good health as determined by the Investigator * Woman of childbearing potential using reliable methods of contraception with a low failure rate (i.e. less than 1% per year), e.g. implants, injectables, combined oral contraceptives, reliable intrauterine-devices, vasectomised/ infertile partner or surgically sterile (uterus removed or both tubes tied) or postmenopausal (at least 2 years without periods)

Exclusion criteria

* 4.2.1 General

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026