Bioequivalence StudyPhase 1NCT04585321

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

A Phase 1 study testing Diclofenac Sodium 140mg Medicated Plaster and Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac in people with Bioequivalence Study, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence Study
What is being tested?: Diclofenac Sodium 140mg Medicated Plaster and Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteItaly
Study dates: 28 Nov 2017to 17 May 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and females, Caucasian/White aged between 18 and 55 years.
BMI between 19 and 29 kg/m² included
Normal or non-clinical significant findings on the physical examination
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.
Willing and able to understand and sign an approved Informed Consent form.
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).

Who cannot join

History of alcohol or drug abuse.
Smokers of more than 10 cigarettes/day.
History of gastrointestinal, renal, hepatic, pulmonary or cardiovascular disease; or history of epilepsy, asthma, diabetes, psychosis or glaucoma.
History of allergic response to diclofenac or related drugs, namely non-steroidal anti-inflammatory agents
Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
Participation in a previous clinical trial within the past 6 months.

Show all 16Show fewer

Blood donation of 250 ml or more within the past 3 months.
Treatment with any known enzyme inhibiting or inducing agents (barbiturates, phenothiazines, etc.) within the past 4 weeks.
Positive to HIV test and/or Hepatitis B and C tests.
Positive to drugs of abuse qualitative screen in urine.
Use of any prescription or over-the-counter medication on a regular basis.
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)
In the judgement of the Clinical Investigator subjects likely to be not compliant or cooperative during the study.
Irritation scale score higher than zero at the sites of application.
Presence of skin injuries at the sites of application.
An acquired tan (by sun or lamp) in the previous 2 weeks

Trial locations and contacts

1 site in 1 country.

Italy1 site

CRC Centro Ricerche Cliniche di Verona s.r.l. c/o Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions: Bioequivalence Study
Being tested: Diclofenac Sodium 140mg Medicated Plaster, Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac Sodium 140mg Medicated PlasterDrug
Also called EQI7
Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days.
Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day.
Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenacDrug
Also called Flector
Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days.
Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day.

Study groups in NCT04585321
Study group	Role	What they receive
T-R	Other	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. Receives: Drug: Diclofenac Sodium 140mg Medicated Plaster; Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac
R-T	Other	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. Receives: Drug: Diclofenac Sodium 140mg Medicated Plaster; Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Css max on Day 7 through Day 9
Measured: Day 7 through Day 9
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
AUCττ on Day 7 through Day 9
Measured: Day 7 through Day 9

Secondary outcomes (14)

Cmax (ng/mL) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1
Cmax on Day 1
Measured: Day 1
AUC (ng/mL*h) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1
AUC on Day 1
Measured: Day 1
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
Adhesivity of plasters with adhesivity 5-point ordinal scale:
0 = >90% adhered; 1 = >75% to <90% adhered; 2 = >50% to <75% adhered; 3 =< 50% adhered but not detached; 4 = Plaster detached, from Day 1 for the entire study period
Measured: From Day 1 for the entire study duration
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
Local tolerability: irritation 8-point categorical scale:0=no evidence of irritation;1=minimal erythema, barely perceptible;2=definite erythema, readily visible;3=minimal edema or minimal papular response;3=erythema and papules;4=definite edema;5=erythema, edema, and papules;6=vescicular eruption;7=strong reaction spreading beyond test site, from Day1 for the entire study duration
Measured: From Day 1 for the entire study duration
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
Local tolerability: symptoms 4-point categorical scale:0=absent;1=mild;2=moderate;3=severe), from Day1 for the entire study duration
Measured: From Day 1 for the entire study duration
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
Heart rate measurement in bpm on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Systolic/diastolic blood pressure in mmHg measurement on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Body temperature in C degrees measurement on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Haematological analysis on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Biochemical analysis on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Virological tests on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Urinalysis on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
12-lead ECG on Day 1 of period 1 and Day 9 of period 2
Measured: Day 1 of period 1 and Day 9 of period 2
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
Incidence of adverse events from Day 1 for the entire study duration
Measured: From Day 1 for the entire study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 201717 May 2018

First posted14 Oct 2020
Study start28 Nov 2017
Primary completion17 May 2018
Study completion17 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bioequivalence StudyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585321
Sponsor's protocol ID: EQI7_17_01
Status last verified: Feb 2020
First submitted: 2 Mar 2020
Last updated: 14 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)

All Bioequivalence Study trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04585321
Acronym / sponsor ID: EQI7_17_01
Conditions: Bioequivalence Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
Study start: 28 Nov 2017 (actual)
Primary completion: 17 May 2018 (actual)
Study completion: 17 May 2018 (actual)
First posted: 14 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
T-R	Other	Drug: Diclofenac Sodium 140mg Medicated Plaster, Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenacPart 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.
R-T	Other	Drug: Diclofenac Sodium 140mg Medicated Plaster, Drug: Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenacPart 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Males and females, Caucasian/White aged between 18 and 55 years.
BMI between 19 and 29 kg/m² included
Normal or non-clinical significant findings on the physical examination
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.
Willing and able to understand and sign an approved Informed Consent form.

Key exclusion criteria (16 listed)

History of alcohol or drug abuse.
Smokers of more than 10 cigarettes/day.
History of gastrointestinal, renal, hepatic, pulmonary or cardiovascular disease; or history of epilepsy, asthma, diabetes, psychosis or glaucoma.
History of allergic response to diclofenac or related drugs, namely non-steroidal anti-inflammatory agents
Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac Sodium 140mg Medicated PlasterAlso: EQI7Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days. Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day.	Drug	R-T, T-R
Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenacAlso: FlectorPart 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days. Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day.	Drug	R-T, T-R

Primary outcome

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
Time frame: Day 7 through Day 9
Css max on Day 7 through Day 9
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
Time frame: Day 7 through Day 9
AUCττ on Day 7 through Day 9

14 secondary outcomes

Cmax (ng/mL) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1
Time frame: Day 1
AUC (ng/mL*h) of Diclofenac Sodium 140mg Medicated Plaster EQI7 and Flector® topical plasters applied once and twice a day on Day 1
Time frame: Day 1
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
Time frame: From Day 1 for the entire study duration
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
Time frame: From Day 1 for the entire study duration
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
Time frame: From Day 1 for the entire study duration
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: Day 1 of period 1 and Day 9 of period 2
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
Time frame: From Day 1 for the entire study duration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Individual participant dataSharing planned: No

Related trials for Bioequivalence Study

Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicola Giordan study director

Fidia Farmaceutici s.p.a.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Day 7 through Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.