Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic
Keywords: heat
exercise
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: 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 Exclusion Criteria

  * Investigator or any other team member involved directly or indirectly in the conduct of the clinical trial
  * Subjects who are inmates of psychiatric wards, prisons, or other state institutions
  * Participation in another clinical trial within the last 30 days
  * Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium)
  * Pregnancy or lactation

4.2.2 Medical History Related Exclusion Criteria

* Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, and ingredients used in pharmaceutical products
* Alcohol or drug abuse
* Malignancy within the past 2 years
* Skin lesions, dermatological diseases or tattoo in the treatment area
* Major surgery 3 months before enrolment
* Impaired haematopoesis and coagulation
* Gastric and duodenal ulcer and gastrointestinal bleedings
* Systemic lupus erythematodes, mixed connective tissue disease
* Major heart disease / uncontrolled hypertension
* Hepatic failure with ALT and/or AST \> 2.0 ULN
* Renal failure with serum creatinine levels \> 1.5 milligrams/deciliter (mg/dL)
* Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
* Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
* HIV - Infection
* Blood donation one (1) month before screening and during study
* Hepatitis B and C
* Asthma bronchiale

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: X-pert Med GmbH
city: Leipzig
country: Germany
facility: ClinPharm Interantional GmbH
Study officials:
affiliation: X-pert Med GmbH
name: Egbert Seidel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: