Study to evaluate the adhesion and bioavailability of Diclofenac 2.6% medicated plaster in healthy volunteers

Phase 1

Completed

• Conditions: DHEP 2.6% medicated plasters for analgesia and anti-inflammatory effects; Not Applicable

• Registration Number: ISRCTN54822524
• Lead Sponsor: IBSA Institut Biochimique S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-28
• Study Start: 2022-06-13
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Signed written informed consent before inclusion in the study
2. Men or women aged between 45 and 65 years inclusive
3. Body Mass Index (BMI) between18.5 and 30 kg/m² inclusive
4. Vital signs measured after 5 min at rest in the sitting position:
4.1. Systolic blood pressure (SBP) 100-139 mmHg
4.2. Diastolic blood pressure (DBP) 50-89 mmHg
4.3 Heart rate 50-90 bpm
5. Able 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. 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.
7. Women 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 12-lead (supine position) electrocardiogram (ECG)
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 or tattoos at the application site or any other physical/medical condition which could interfere with the objectives of the study
5. Known or presumed hypersensitivity to the active principle and/or formulations' ingredients
6. History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
7. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine or neurological diseases that may interfere with the aim of the study
8. Medications, including over the counter (OTC) medications (in particular, non-steroidal anti-inflammatory drugs) and herbal remedies, used within the 2 weeks before the start of the study. Hormonal contraceptives for women will be allowed.
9. Participation in the evaluation of any investigational product within the 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.
10. Blood donations within the 3 months before this study
11. History of drug, alcohol (>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025), caffeine (>5 cups coffee/tea/day), or tobacco abuse (=10 cigarettes/day)
12. Positive result at the drug test at screening or Day -1
13. Positive alcohol breath test at Day -1
14. Abnormal diets (<1600 or >3500 kcal/day), vegetarian diet, or substantial changes in eating habits in the 4 weeks before this study
15. Positive or missing pregnancy test at screening or Day -1
16. Pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified