Healthy volunteers Other
Conditions
Interventions
Test product: IBSA Lidocaine 5% medicated plaster, IBSA Institut Biochimique S.A., Switzerland
Reference product: Versatis® (lidocaine) 700 mg medicated plaster, Grünenthal, Österreich
For each par
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: men and women, 30-65 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 50-99 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 co-operate 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 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
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. Application site: diseased-skin, skin wounds, abrasions, open injuries, tattoos, scars, moles or other abnormal pigmentation of the skin at the application site or any other physical/medical condition which could interfere with the objectives of the study 5. Allergy: ascertained or presumptive hypersensitivity to lidocaine or formulations' ingredients or both; ascertained or presumptive hypersensitivity to other amide local anaesthetics, such as bupivacaine, etidocaine, mepivacaine or prilocaine; ascertained or presumptive hypersensitivity to medical plasters; 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, immunological 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 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], caffeine (>5 cups coffee/tea/day) or tobacco abuse (>=10 cigarettes or electronic cigarettes/day) 11. Drug test: positive result at the urine drug test at screening or Day -1 12. Alcohol test: positive saliva alcohol test at screening or Day -1 13. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians and vegans 14. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and, if feasible, AUC0-8 of plasma lidocaine after single application of test and reference. These parameters were evaluated analysing venous blood samples collected from participants’ forearm veins at the following times: On Day 1 of each study period at pre-application (0) and 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 15 h post-application On Day 2 of each study period at 18, 21, 24, 30 and 36 h post-application | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma lidocaine concentration profile and pharmacokinetic parameters (tmax and, if feasible, %AUCextra, t1/2 and ?Z) of plasma lidocaine after single application of test and reference. These parameters were evaluated analysing venous blood samples collected from participants’ forearm veins at the following times: On Day 1 of each study period at pre-application (0) and 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 15 h post-application On Day 2 of each study period at 18, 21, 24, 30 and 36 h post-application 2. Adhesion scores and estimated percentages of adhered plaster area for test and reference. Plaster adhesion was evaluated on Day 3 of each study period immediately after the application (0 h), at 2, 4 and 8 h post-application, and immediately before the plaster removal (12 h post-application). The assessment was visually performed using a specific 6-point scale. In addition, at each time point, the actual percentage adhesion value (%) was estimated. 3. Treatment-emergent adverse events, vital signs (blood pressure, heart rate), ECG, local tolerability, physical examination, body weight, clinical laboratory parameters. Vital signs were evaluated through a sphygmomanometer approximately at each visit. ECG, visual physical examination, and body weight (through an electronic weighing scale) were evaluated at screening and final visits. Local tolerability was evaluated in all subjects on Day 1, before plasters’’ application and after plasters’ removal. Skin reactions were scored according to a specific four-grade scale. Other outcomes measures (qualitative aspects): 1. Presence of residual adhesive paste on the release liner at the removal from each plaster 2. Presence of residual adhesive paste on the skin of the application site after plaster removal 3. Presence of a cold-flow, i.e., the formation of a dark ring around the plaster during the application time 4. Movement, displacement or wrinkling of the plaster during the application time All qualitative aspects were visu | — |
Countries
Italy, Switzerland
Contacts
Public ContactSerena Tettamanti
Outcome results
None listed