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

IDEA AG

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic

Treatments: Drug: Diractin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745264

CL-033-I-04

Details and patient eligibility

About

• 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

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

2

Experimental group

Description:

400 mg Ketoprofen from Diractin to 4 joints

Treatment:

Drug: Diractin

Drug: Diractin

Drug: Diractin

Drug: Diractin

3

Experimental group

Description:

100 and 400 mg Ketoprofen used concomittant with heat

Treatment:

Drug: Diractin

Drug: Diractin

Drug: Diractin

Drug: Diractin

4

Experimental group

Description:

100 and 400 mg Ketoprofen concomittant with moderate exercise

Treatment:

Drug: Diractin

Drug: Diractin

Drug: Diractin

Drug: Diractin

1

Experimental group

Description:

100 mg ketoprofen to 2 joints

Treatment:

Drug: Diractin

Drug: Diractin

Drug: Diractin

Drug: Diractin