A Pilot Study to Evaluate the Relative Bioavailability of Diclofenac as Measured by Microdialysis After Repeated Doses of Two Topical Diclofenac Formulations - A Pilot Study to Evaluate the Relative Bioavailability of Two Topical Diclofenac Formulations

• Conditions: ot applicable as this study is to compare the extent of absorption of two topical gels.

• Registration Number: EUCTR2007-005486-34-AT
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1)Subject is a healthy male Caucasian between 18 - 55 years of age (inclusive).
2)Subject has a body mass index between 20 - 30kg/m2 (inclusive).
3)Subject is in good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities as assessed by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests.
4)Subject understands and is willing, able, and likely to comply with all study requirements, procedures, and restrictions.
5)Subject demonstrates a willingness to participate as evidenced by voluntary written informed consent.

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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Subject has any clinically relevant acute or chronic disease, which could interfere with his safety during the clinical trial or expose him to undue risk through the participation in the trial or which could interfere with the study objective.
2)Subject has a known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver, kidney or other disease, unless deemed not clinically significant by the investigator.
3)Subject has significant physical or organ abnormality.
4)Subject has a skin disease and/or skin abnormalities (e.g. dermatitis, eczema, psoriasis, significant dryness, skin lesions) at or near the site of drug application.
5)Subject has known skin sensitivity to topical applications.
6)Subject has any clinically significant allergy or history of severe allergic reaction, especially skin allergies.
7)Subject has drug hypersensitivity or known hypersensitivity to diclofenac, NSAIDs, or aspirin (e.g., asthma).
8)Subject has a psychiatric illness.
9)Subject has current or recent history of abuse or addiction (alcohol, drugs or substances).
10)Subject has participated in a clinical trial within the last 30 days prior to the first scheduled dosing of this trial.
11)Subject is currently using or has used within the 14 days immediately prior Visit 2, any prescription medication, over-the-counter medication, or herbal supplement.
12)Subject is currently using or has used within the 30 days immediately prior Visit 2, any prescription or over-the-counter medication containing diclofenac.
13)Subject has had blood loss of more than 450ml within the six weeks immediately prior to Visit 2 or intended blood donation within the six weeks immediately after his or her last visit.
14)Subject has consumed excessive amounts of caffeine judged to be excessive by investigator.
15)Subject requires a special diet (e.g. vegetarian diet).
16)Subject is an employee of the sponsor or the clinic site or members of their immediate family.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine if quantifiable concentrations of diclofenac can be measured in microdialysis samples of subcutaneous adipose and skeletal muscle tissue and to ascertain the associated plasma concentration of diclofenac after repeated topical administration of Panadol Diclofenac Gel.;Primary end point(s): The primary endpoints in determining this will be AUC0-10hr, Cmax, Tmax and T1/2.;Secondary Objective: The secondary objectives are to determine if quantifiable concentrations of diclofenac can be measured in microdialysis samples of subcutaneous adipose and skeletal muscle tissue and to ascertain the associated plasma concentration of diclofenac after repeated topical administration of Voltarol Emulgel P and to assess the safety and tolerability of the study regimens as measured by the incidence of adverse events