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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pharmacokinetic

Intervention / Treatment
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* Drug: Diractin
* Drug: Diractin
* Drug: Diractin
* Drug: Diractin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>400 mg Ketoprofen from Diractin to 4 joints | Drug: Diractin<br>* 400 mg ketoprofen to 4 joints<br>|
| Experimental: 3<br>100 and 400 mg Ketoprofen used concomittant with heat | Drug: Diractin<br>* 100 and 400 mg Ketoprofen used concomittant with heat<br>|
| Experimental: 4<br>100 and 400 mg Ketoprofen concomittant with moderate exercise | Drug: Diractin<br>* 100 and 400 mg Ketoprofen concomittant with moderate exercise<br>|
| Experimental: 1<br>100 mg ketoprofen to 2 joints | Drug: Diractin<br>* 100 mg Ketoprofen to 2 joints<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heat, exercise