A study to investigate drug concentrations in the skin using a special dermal sampling technique
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]Healthy Volunteers
- Registration Number
- EUCTR2020-002101-25-AT
- Lead Sponsor
- HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
1. Healthy, adult volunteers of age 18 to 65 years (both inclusive).
2. Males or non-pregnant, non-breast feeding females using adequate contraceptive methods or abstinence.
3. Able to read, understand and sign the written informed consent form.
4. Willing to follow the protocol requirements and comply with protocol restrictions.
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 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Social habits
a. Smoker who is not willing to refrain from smoking during the in-house visit.
b. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
2. Medications: Use of any medications other than hormonal contraceptive, hormone replacement therapy or routine vitamins within the 7 days or 5 half-life periods whichever is longer prior to the initial dose of study medication.
3. Diseases: Presence of any clinically relevant acute or chronic disease, which in the investigator´s opinion might jeopardise subject`s safety, evaluation of results or compliance with the protocol.
4. Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
5. Any abnormalities found during physical examination or vital signs, unless deemed not clinically significant by the investigator.
6. Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
7. Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
8. Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
9. Positive HIV test.
10. Positive alcohol breath test.
11. Blood donation within 30 days or significant loss of blood or plasma (more than 550 ml) within 90 days prior to screening.
12. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
13. Known hypersensitivity to diclofenac or any components of the drugs.
14. Tattoos or broken and/or damaged skin and/or scarring at the application areas.
15. Active skin diseases like psoriasis or atopic dermatitis, as judged by the investigator.
16. Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
17. Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
18. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities for 14 days after Visit 2 to ensure good tissue regeneration.
19. Not willing to refrain from shaving the planned treatment sites or using skin care products on the planned treatment sites for at least 5 days prior to start of Visit 2.
20. Pronounced hairiness on the planned treatment sites that may negatively affect BE testing.
21. Known allergy/hypersensitivity to any of the materials/supplies used during the study.
22. Presence of needle phobia.
23. Not enough space on the thighs for the dOFM probe set-up (
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method