A study to assess the amount of drug that reaches the blood circulation of a new anti-inflammatory medicated plaster applied once a day in comparison with the similar medicated plaster (Flector®) applied twice a day in healthy volunteers

Phase 1

Completed

• Conditions: DHEP-medicated plaster for analgesia or anti-inflammatory effects; Not Applicable

• Registration Number: ISRCTN13261615
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-06
• Study Start: 2021-04-07
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Signed written informed consent
2. Aged between 18 and 55 years, inclusive
3. Body Mass Index (BMI) between 18.5 and 30 kg/m² inclusive
4. Systolic blood pressure between 100 and 139 mmHg, diastolic blood pressure between 50 and 89 mmHg, and heart rate between 50 and 90 bpm, measured after 5 min at rest in the sitting position
5. The ability to comprehend the full nature and purpose of the study, including possible risks and side effects, and the ability to co-operate with the Investigator and to comply with the requirements of the entire study
6. 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 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
7. Female participants of non-child-bearing potential or in post-menopausal status for =1 year
8. Negative pregnancy test result at screening and day -1

Exclusion Criteria

1. Clinically significant abnormalities on electrocardiogram (12-leads, supine position)
2. Clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Clinically significant abnormal laboratory values indicative of physical illness
4. Diseased-skin, skin wounds, open injuries, tattoos, or the use of makeup, creams, lotions, powders, or other topical products at the application site
5. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients or history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of the Investigator could affect the outcome of the study
6. History of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
7. Medications including over the counter medications and herbal remedies, for 2 weeks before the start of the study, with the exception of hormonal contraceptives for women
8. 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.
9. Blood donations for 3 months before this study
10. History of drug, alcohol (>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day), or tobacco abuse (=10 cigarettes/day)
11. Positive result at the drug test at screening or day -1
12. Positive alcohol breath test at day -1
13. Abnormal diets (<1600 or >3500 kcal/day), substantial changes in eating habits in the 4 weeks before this study, or a vegetarian diet
14. Pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioavailability and pharmacokinetic parameters measured using the diclofenac plasma concentrations in blood samples collected at 0 (pre-application), 0.5, 1, 2, 3, 4, 6, 9, 12, 12.5, 13, 14, 15, 16, 18, 21, and 24 h post-application (or after the first application for the Reference plaster) on day 1 of both study periods; at 0 h on day 3 of both study periods; and at 0 (pre-application), 1, 2, 4, 6, 9, 12, 13, 14, 16, 18, 21, and 24 h post-application (or after the first application for the Reference plaster) on day 5 of both study periods

Secondary Outcome Measures

Name	Time	Method
<br> Safety and tolerability measured using the following:<br> 1. Incidence of treatment-emergent adverse events (TEAEs) throughout the study period<br> 2. Vital signs (blood pressure and heart rate) at 0 and 24 h on day 1 and day 5 of both study periods<br> 3. Clinical laboratory assays of blood and urine samples at 6 days during period 2<br>