Preliminary study with the aim to assess the effect on humans and the amount of a drug that reaches the blood circulation when using a newly developed plaster containing the painkiller diclofenac in comparison with the marketed diclofenac medicated plaster (Flector EP Tissugel®)
- Conditions
- Tolerability and bioavailability of a new DHEP medicated plaster versus a market reference formulation on healthy subjectsNot Applicable
- Registration Number
- ISRCTN26063832
- Lead Sponsor
- IBSA Institut Biochimique (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
1. Informed Consent: signed written Informed Consent before inclusion in the study
2. Sex and Age: males and females, 18-45 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
6. Contraception and fertility (women only): women of childbearing potential must be using at least one of the following reliable methods of contraception:
6.1. Hormonal oral, implantable, intrauterine device [IUD], transdermal or injectable contraceptives for at least 2 months before the screening visit
6.2. A non-hormonal 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 screeningvisit;
6.3. A male sexual partner who agrees to use a male condom with spermicide
6.4. A sterile sexual partner
Women of non-childbearing potential or in post-menopausal status for at least 1 year will be admitted.
For all women, pregnancy test result must be negative at screening and Day -1 of each study period.
1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study and which the investigator considers may affect the outcome of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Application site: diseased-skin, skin wounds, open injuries or tattoos at the application site
5. 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
6. Diseases: history of clinically significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
7. Medications: medications, including over the counter medications and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
8. 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
9. Blood donation (Population subgroup for PK analysis only): blood donations for 3 months before this study
10. 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] or caffeine abuse (>5 cups
coffee/tea/day) or tobacco abuse (=10 cigarettes/day)
11. Drug test: positive result at the drug test at screening or Day-1
12. Alcohol test: positive alcohol breath test at Day -1
13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
14. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Local tolerability of diclofenac is evaluated as adverse drug reactions (ADRs) at the application site measured after application for 2 consecutive days, including:<br> 1.1. Application site erythema, dryness, swelling and exfoliationass essed by the investigator using a 4-grade scale<br> 1.2. All other treatment-related AEs occurring at the application site, spontaneously reported by the subjects or observed by the investigator<br>
- Secondary Outcome Measures
Name Time Method