E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Not applicable as this study is to compare the extent of absorption of two topical gels. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints in determining this will be AUC0-10hr, Cmax, Tmax and T1/2. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Degree of subcutaneous absorption |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 30 |