Pharmacokinetics of calcipotriol after Daivonex® cream applicatio

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 8

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and age: males, 18-55 years old inclusive
3. Body Mass Index: 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study

Exclusion Criteria

1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; in particular skin damages, tattoos or any abnormal findings in the back
2. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
3. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
4. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; known or suspected disorders of calcium metabolism associated with hypercalcaemia
5. Medications: medications, including over the counter medications and herbal remedies, calcium, vitamin D or vitamin-like medicines (e.g. calcitriol) for 2 weeks before the start of the study
6. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
7. Blood donation: blood donations for 3 months before this study
8. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day, defined according to the USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day)
9. Drug test: positive result at the drug test at screening
10. Alcohol test: positive alcohol breath test at day -1
11.Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians