Status:
COMPLETED
Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
Lead Sponsor:
IDEA AG
Conditions:
Pharmacokinetic
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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) * ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00745264
Start Date
October 1 2007
End Date
May 1 2008
Last Update
March 20 2009
Active Locations (2)
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1
X-pert Med GmbH
Jena, Germany
2
ClinPharm Interantional GmbH
Leipzig, Germany