Clinical trial NCT04585321: Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day
Official title: Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day to Healthy Volunteers With a Repeat Dose Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence Study
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the reference medicinal product Flector®, applied once and twice a day.

Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy volunteers in comparison to the reference medicinal product Flector®, applied once and twice a day.

Detailed description: Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the reference medicinal product Flector®, both formulated as topical plasters applied once and twice a day.

Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy volunteers in comparison to the reference medicinal product Flector®, both formulated as topical plasters applied once and twice a day.

Eligibility criteria: Inclusion Criteria:

1. Males and females, Caucasian/White aged between 18 and 55 years.
2. BMI between 19 and 29 kg/m² included
3. Normal or non-clinical significant findings on the physical examination
4. Normal or non-clinical significant finding on the laboratory evaluations. Laboratory values outside the normal range will be carefully evaluated by the clinical investigator. Subject showing safety laboratory values outside the normal range, but judged not clinically significant, may be allowed to enter the study. For sodium and potassium no values outside the normal range will be allowed.
5. Willing and able to understand and sign an approved Informed Consent form.
6. If female, they must not be pregnant or breast feeding and using an effective contraception method during the study (hormonal, such as birth control pill, or barrier method, such as condom or diaphragm, or intrauterine, such as spiral).

Exclusion Criteria:

1. History of alcohol or drug abuse.
2. Smokers of more than 10 cigarettes/day.
3. History of gastrointestinal, renal, hepatic, pulmonary or cardiovascular disease; or history of epilepsy, asthma, diabetes, psychosis or glaucoma.
4. History of allergic response to diclofenac or related drugs, namely non-steroidal anti-inflammatory agents
5. Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
6. Participation in a previous clinical trial within the past 6 months.
7. Blood donation of 250 ml or more within the past 3 months.
8. Treatment with any known enzyme inhibiting or inducing agents (barbiturates, phenothiazines, etc.) within the past 4 weeks.
9. Positive to HIV test and/or Hepatitis B and C tests.
10. Positive to drugs of abuse qualitative screen in urine.
11. Use of any prescription or over-the-counter medication on a regular basis.
12. Drinking excessive amounts of tea, cacao, coffee and/or beverages containing caffeine (\> 5 cups/day) or wine (\> 0,5 l/day) or spirits (\> 50 ml/day)
13. In the judgement of the Clinical Investigator subjects likely to be not compliant or cooperative during the study.
14. Irritation scale score higher than zero at the sites of application.
15. Presence of skin injuries at the sites of application.
16. An acquired tan (by sun or lamp) in the previous 2 weeks

Primary outcomes:
measure: Css max (ng/mL) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 7 through Day 9
timeFrame: Day 7 through Day 9
measure: AUCττ (ng/mL*h) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 7 through Day 9
timeFrame: Day 7 through Day 9
Secondary outcomes:
measure: Cmax (ng/mL) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1
timeFrame: Day 1
measure: AUC (ng/mL*h) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1
timeFrame: Day 1
measure: Adhesivity of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to Flector® topical plasters applied once and twice a day with a 5-point ordinal scale, where 0= >90%adhered and 4=plaster detached, from Day 1 for the entire study period
timeFrame: From Day 1 for the entire study duration
measure: Local tolerability of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to Flector® topical plasters applied once and twice a day, with the irritation8-point scale, where 0=no evidence of irritation and 7=strong reaction, from Day1 onward
timeFrame: From Day 1 for the entire study duration
measure: Local tolerability of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to Flector® topical plasters applied once and twice a day, with the syntoms 4-point categorical scale score, where 0=absent and 3=severe, from Day1 onward
timeFrame: From Day 1 for the entire study duration
measure: Measurement of heart rate in bpm during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Measurement of systolic/diastolic blood pressure in mmHg during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Measurement of body temperature in C degree during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Haematological analysis during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Biochemical analysis during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Virological tests during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Urinalysis during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: 12-lead ECG evaluation during treatment with Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1 of period 1 and Day 9 of period 2
timeFrame: Day 1 of period 1 and Day 9 of period 2
measure: Incidence of adverse events using Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day from Day 1 for the entire study duration
timeFrame: From Day 1 for the entire study duration
Other outcomes:
Locations:
city: Verona
country: Italy
facility: CRC Centro Ricerche Cliniche di Verona s.r.l. c/o Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
affiliation: Fidia Farmaceutici s.p.a.
name: Nicola Giordan
role: STUDY_DIRECTOR
References: