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

NCT00745264 | Completed Phase 1

• 1 other identifier: CL-033-I-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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)
• 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

Conditions

Pharmacokinetic

Keywords

heat; exercise

Study Arms (4)

2

EXPERIMENTAL

400 mg Ketoprofen from Diractin to 4 joints

Drug: Diractin

3

EXPERIMENTAL

100 and 400 mg Ketoprofen used concomittant with heat

Drug: Diractin

4

EXPERIMENTAL

100 and 400 mg Ketoprofen concomittant with moderate exercise

Drug: Diractin

1

EXPERIMENTAL

100 mg ketoprofen to 2 joints

Drug: Diractin

Interventions

Diractin DRUG

100 mg Ketoprofen to 2 joints

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• IDEA AG: lead

Study Sites (2)

X-pert Med GmbH

Jena, Germany

Location

ClinPharm Interantional GmbH

Leipzig, Germany

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Egbert Seidel, MD, PhD

  X-pert Med GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

DE (2)