The study population is a healthy population who are voluntarily participating in this clinical trial. This study will compare the PK profile after e.c. and oral application of the same dosage of ketoprofen and in a dosage range as intended for clinical use in OA. It will also indicate whether application on muscle will result in a different PK profile as compared to application on a joint. The intended use for Diractin® will be osteoarthritis of the knee MedDRA version: 9.1 Level: LLT Classifi
Conditions
Interventions
Product Name: Diractin®
Pharmaceutical Form: Gel
INN or Proposed INN: Ketoprofen
CAS Number: 22071-15-4
Current Sponsor code: 033/23
Concentration unit: mg/g milligram(s)/gram
Concentration type: eq
Sponsors
IDEA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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) • Muscle soreness with a pain score of at least 3 on a 10 point categorical pain scale at 12-16h after exercise Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 and during study • Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium) • Pregnancy or lactation • History of dermal allergic reactions • 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 • NSAID idiosyncrasy • 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 • Hepatitis B or C • Blood donation one month before screening and during the study • Asthma bronchiale • Medication during the study observation period (Screening to final Visit) containing o Digoxin o Phenytoin o Lithium o Glucocorticoids o NSAID´s o Probenecid o Sulfinpyrazon • Diuretics during the study observation period (Screening to final Visit) • ACE inhibitors during the study observation period (Screening to final Visit) • Anticoagulants during the study observation period (Screening to final Visit) • Methotrexat during the study observation period (Screening to final Visit) • Antacids during the study observation period (Screening to final Visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: – Evaluation of reduction in pain caused by muscle soreness after application of 200 mg ketoprofen from Diractin® per b.i.d. in comparison to placebo. – Evaluation of reduction in pain caused by muscle soreness after application of 100 mg ketoprofen from Diractin® b.i.d. in comparison to placebo. ;Secondary Objective: Secondary: –Evaluation of reduction in pain caused by muscle soreness after application of 100 mg ketoprofen from oral application b.i.d. in comparison to placebo;Evaluation of reduction in pain caused by muscle soreness after application of 200 mg ketoprofen from Diractin® in comparison to 100 mg ketoprofen from oral application b.i.d.; Evaluation of reduction in pain caused by muscle soreness after application of 100 mg ketoprofen from Diractin® in comparison to 100 mg ketoprofen from oral application b.i.d.; Evaluation of the plasma pharmacokinetics after single application; 100 mg ketoprofen from Diractin®; 200 mg ketoprofen from Diractin®;100 mg from oral ketoprofen; Comparison of the plasma pharmacokinetics after 7 days of b.i.d. application of –100 mg ketoprofen from Diractin® –200 mg ketoprofen from Diractin® –100 mg from oral ketoprofen –Evaluation of safety and tolerability of Diractin® in comparison to placebo and oral ketoprofen ;Primary end point(s): Primary endpoint : The area under the curve of muscle pain scores evaluated by a 10 point categorical pain scale at 15 min, 30 min, 1h, 2h, 4h, 8h, 12 h after the first application (the 12 h evaluation should be done immediately the before 2nd application) and then always before the next application. Secondary endpoints: The area under the curve of muscle soreness within the first 12 hours after the first application. AUCss, Cmax,ss, Cmin,ss for day 7 assessments AUC0-12, Cmax for day 1 assessments | — |
Countries
Germany
Outcome results
None listed