Study to assess the active substance bioavailability (amount of the drug that reach the blood circulation), adhesion and tolerability of the medicated plaster Flector Unidie® applied once a day for 5 consecutive days to healthy volunteers

Phase 1

• Conditions: Evaluation of bioavailability, adhesion and tolerability of Flector Unidie® medicated plaster applied once a day for 5 consecutive days to healthy volunteers; Not Applicable

• Registration Number: ISRCTN59179622
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-27
• Last Update Posted: 6 November 2023
• Study Completion: 2023-11-08

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: men/women, 18-55 years old inclusive
3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 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 cooperate with the Investigator and to comply with the requirements of the entire study
6. Contraception and fertility (women only): women 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 (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 agrees to use a male condom with spermicide
6.4. A sterile sexual partner.
or:
True abstinence (i.e., refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), lactational amenorrhea, and withdrawal are not acceptable.
Women of non-child-bearing 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.

Exclusion Criteria

1. Electrocardiogram (ECG) 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. Application site: diseased skin, skin wounds, open injuries or tattoos on both deltoid muscles or any other physical/medical condition which could interfere with the objectives of the study
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: significant history of 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 (OTC) medications (in particular, non-steroidal anti-inflammatory drugs) and herbal remedies, for 2 weeks before the start of the study. Hormonal contraceptives for women 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: blood donations for 3 months before this study
10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025 (18)], caffeine (>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day)
11. SARS-CoV-2 test: positive COVID-19 rapid test at screening or Day -1
12. Drug test: positive result at the drug test at screening or Day -1
13. Alcohol test: positive alcohol saliva test at screening or Day -1
14. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians and vegans
15. 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