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

Pharmacokinetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745264
• Other study ID #: CL-033-I-04
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2008
• Last updated: March 19, 2009
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2009
• Source: IDEA AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetic

Intervention

Drug:
• Diractin
100 mg Ketoprofen to 2 joints
• Diractin
400 mg ketoprofen to 4 joints
• Diractin
100 and 400 mg Ketoprofen used concomittant with heat
• Diractin
100 and 400 mg Ketoprofen concomittant with moderate exercise

Locations

Country	Name	City	State
Germany	X-pert Med GmbH	Jena
Germany	ClinPharm Interantional GmbH	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
IDEA AG

Country where clinical trial is conducted

Germany,