Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day

Fidia Pharma

Status and phase: Completed; Phase 1

Conditions: Bioequivalence Study

Treatments: Drug: Diclofenac Sodium 140mg Medicated Plaster; Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac

Study type: Interventional

Funder types: Industry

Identifiers

NCT04585321

EQI7_17_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

T-R

Other group

Description:

Part 1 (QD) and part 2 (BID): Period 1: Test drug (T): Diclofenac Sodium 140mg Medicated Plaster EQI7, topical plaster. Period 2: Reference drug (R): Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac.

Treatment:

Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac

Drug: Diclofenac Sodium 140mg Medicated Plaster

R-T

Other group

Description:

Part 1 (QD) and part 2 (BID): Period 1: Reference drug (R): Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac. Period 2: Test drug (T): Diclofenac Sodium 140mg Medicated Plaster EQI7, topical plaster.

Treatment:

Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac

Drug: Diclofenac Sodium 140mg Medicated Plaster