DHEP-medicated plaster Skin and Connective Tissue Diseases DHEP-medicated plaster
Conditions
Interventions
The study consists of a screening visit, a treatment phase of one study period and a final visit/early termination visit (ETV).
For each subject, two DHEP-Heparin medicated plasters are applied concu
Sponsors
IBSA Institut Biochimique SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: males/females, 18-55 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 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 6. Contraception and fertility (females only): females of child-bearing potential must be using at least one of the following reliable methods of contraception: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 6.3. A male sexual partner who agreed to use a male condom with spermicide 6.4. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year are admitted. For all female subjects, pregnancy test result had to be negative at screening and at each scheduled evaluation.
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-leads, supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. 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 considered could affect the outcome of the study 5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study 6. Application site: diseased-skin, skin wounds or open injuries at the applications site 7. Medications: medications, including over the counter medications and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for females were allowed 8. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was 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 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020], caffeine (>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day) 10. Drug test: positive result at the drug test at screening 11. Alcohol test: positive alcohol breath test at day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adhesion score for the investigational plaster without reinforcement (PW) is measured the 5-point scale at 4, 8, 12, 16, 20 and 24 h post-application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and general tolerability of the IMP were based on the following assessments: Record of adverse events Adverse events (AEs) were assessed throughout the study. Vital signs Subjects’ blood pressure and heart rate were measured by the investigator or his deputy after 5 min at rest in the sitting position at screening, on days 1-2 at pre-dose and 24 h post-application, and in case of ETV. The vital signs measurement at 24 h post-dose was considered as the final assessment. Electrocardiograms A 12-lead resting ECG was performed in supine position at screening and interpreted by the investigator. Physical examination and body weight A physical examination was performed at screening .Body weight, height and body mass index (BMI) were recorded at screening only. Subjects were weighed (kg) lightly clothed without shoes. BMI was calculated as weight [kg] / (height [m] squared). Laboratory analysis 1. Routine haematology, blood chemistry and urinalysis laboratory tests were performed, under fasting conditions, at screening. 2. Haematology: leukocytes and leukocyte differential count (percentage and absolute values), erythrocytes, haemoglobin (conv. units), haemoglobin (IS units), haematocrit, MCV, MCH, MCHC, thrombocytes. Blood Chemistry: 1. Electrolytes: sodium, potassium, calcium, chloride, inorganic phosphorus 2. Enzymes: alkaline phosphatase, ?-GT, AST, ALT 3. Substrates/metabolites: total bilirubin, creatinine, fasting glucose, urea, uric acid, total cholesterol, triglycerides Proteins: total proteins Serum pregnancy test (women only, at screening) Urine analysis: 1. Urine chemical analysis (stick): pH, specific weight, appearance, colour, nitrites, proteins, glucose, urobilinogen, bilirubin, ketones, haematic pigments, leukocytes 2. Urine sediment (analysis performed only if positive): leukocytes, erythrocytes, flat cells, round cells, crystals, cylinders, mucus, bacteria 3. Urine pregnancy test (women only, on day -1). 4. erum virology: Hepatitis B ( | — |
Countries
Switzerland
Outcome results
None listed