DHEP-medicated plaster Not Applicable
Conditions
Interventions
Test treatment 1: Diclofenac-N-(2-hydroxyethyl)-pyrrolidine (DHEP) medicated plaster 2.6%, corresponding approximately to 280 mg of diclofenac sodium
Test treatment 2: Diclofenac-N-(2-hydroxyethyl)-py
Sponsors
IBSA Institut Biochimique S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. 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 were required to use 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 [IUD] 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 were 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. 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 7. 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 followed the last visit of the previous study and the first day of the present study 8. Blood donation: blood donations for 3 months before this 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 2010)], 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 |
|---|---|
| Pharmacokinetic profile of diclofenac in plasma after o.d. application for 2 consecutive days of DHEP-medicated plaster - plasma concentrations of diclofenac measured on day 1 at pre-dose (0) and on days 2-3 at pre-dose (0) and 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 h post-dose (13 samples each study period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability after o.d. application for 2 consecutive days of DHEP-medicated plaster, based on the following assessments: 1. Record of adverse events, assessed throughout the study 2. Vital signs: blood pressure (BP) and heart rate (HR), measured at rest (5 min in sitting position) by the investigator or his deputy at the screening visit, on day -1, as well as on day 3 at 24 h post-dose in each period, and in case of ETV. The vital signs measurement at 24 h post-dose of day 3, period 3, was considered as the final assessment 3. Electrocardiograms: a 12-lead resting ECG performed in supine position and interpreted by the investigator at screening 4. Physical examination and body weight: a physical examination, including measurement of BW, performed at screening and final visit/ETV 5. Routine haematology, blood chemistry and urinalysis laboratory tests performed, under fasting conditions, at screening and at the final visit/ETV 6. Local tolerability, assessed giving a score according to the a 4-grade scale to each of the following parameters: Application site erythema, Application site dryness, Application site swelling, Application site exfoliation (If the score assigned was 1, 2 or 3, the local reaction was treated as an AE with intensity mild (score 1), moderate (score 2) or severe (score 3), while the severity of 0 score was none 7. Plaster adhesiveness, assessed using the 5-point scale in compliance with FDA suggested scoring system for adhesion of transdermal patches, immediately before plaster removal on days 2 and 3 | — |
Countries
Switzerland
Outcome results
None listed