An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM)

• Status: Completed
• Trial end date: 2018-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The overall aim of this clinical pilot study is to develop an optimal design (e.g. dose, study duration) for the main clinical study. In the main study factors that influence dOFM data variability will be measured to develop a general BE testing method using dOFM for dermatological drug products.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Joanneum Research Forschungsgesellschaft mbH
• Treatments: EMLA; Lidocaine; Prilocaine

Criteria

Inclusion Criteria:

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

1. 18 to 65 years inclusive,

2. Males and/or non-pregnant, non-breastfeeding females (subjects need to be informed about adequate contraceptive methods).

3. Able to read, understand, and sign the written informed consent form.

4. Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

1. Social Habits

1. Smoker who is not willing to restrain from smoking during the in-house-visit (Visit 2).

2. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.

2. Medications

a. Use of any medications (specially medication referred in the prescription information of the products) other than hormonal contraceptive or hormone replacement therapy within the 7 days or 5 half-life periods whichever is longer prior to the initial dose of study medication.

3. Diseases

1. Congenital or idiopathic methemoglobinemia

2. Glucose-6-phosphate dehydrogenase deficiencies

3. Presence of any acute or chronic disease or malignancies unless deemed not clinically significant by the investigator.

4. Any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.

5. Any abnormalities found at 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. Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator, could contraindicate the subject's participation in this study.

14. Known or suspected allergy/hypersensitivity to lidocaine or prilocaine, known history of sensitivity to local anesthetics of the amide type or to any other component of the product, other related products, or any inactive ingredients.

15. Tattoos or broken and/or damaged skin at the application areas.

16. Active skin diseases like psoriasis or atopic dermatitis judged by the investigator.

17. Scarring at the anterior part of the thighs

18. Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.

19. Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.) judged by the investigator.

20. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities between Visit 2 and the End-of-Study examination to ensure good tissue regeneration.

21. Not willing to refrain from shaving the anterior of the thighs or using skin care products on the anterior of the thighs for at least 5 days prior to start of Visit 2.

22. Pronounced hairiness on the thighs that may negatively affect BE testing.

23. Known allergy/hypersensitivity to any of the materials/supplies used during the study.

24. Presence of needle phobia.