HealthyPhase 1NCT04670601
Bioequivalence of Flurbiprofen Lozenge vs Strepfen
A Phase 1 study testing Flurbiprofen Test 8.75 MG and Flurbiprofen Reference 8.75 MG in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial summary
The present study has been designed to compare flurbiprofen pharmacokinetic profile after administration of flurbiprofen 8.75 mg lozenges, marketed by ACRAF, S.p.A., Italy (test product), and the marketed Strepfen 8.75 mg honey and lemon lozenges reference product. (Reckitt Benckiser Portugal SA). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flurbiprofen Test 8.75 MG and Flurbiprofen Reference 8.75 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jun 2018to 15 Jul 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
- Informed consent: signed written informed consent before inclusion in the study.
- Sex and Age: males and females, 18-55 years old inclusive.
- Habits: non smokers.
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
- Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position.
- 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.
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- Contraception and fertility (women only): females of child-bearing potential must be using at least one of the following reliable methods of contraception:
- Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- 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
- A male sexual partner who agrees to use a male condom with spermicide
- A sterile sexual partner 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.
Who cannot join
- Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities.
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; subjects with dry mouth conditions or with any other diseases/problems of the mouth which the investigator considers may affect the outcome of the study.
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study.
- Medications: medications, including over the counter (OTC) medications and herbal remedies, in particular flurbiprofen, for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
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- 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
- Blood donation: blood donations for 3 months before this study
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020 (9)], or caffeine abuse (>5 cups coffee/tea/day); smokers
- Drug test: positive result at the drug test at screening or day-1
- Alcohol test: positive alcohol breath test at day -1
- Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- Pregnancy (women only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Flurbiprofen 8.75 mg Lozenge vs. the Reference Product Strepfen 8.75 mg Lozenge in Healthy Volunteers
The present study has been designed to compare flurbiprofen pharmacokinetic profile after administration of flurbiprofen 8.75 mg lozenges, marketed by ACRAF, S.p.A., Italy (test product), and the marketed Strepfen 8.75 mg honey and lemon lozenges reference product. (Reckitt Benckiser Portugal SA).
Read the detailed description
This is a single dose, open-label, randomised, 2-way cross-over bioequivalence study aimed to compare the bioavailability and the plasma pharmacokinetic profile of flurbiprofen after single dose administration of test and reference formulations.
- Conditions
- Healthy
- Being tested
- Flurbiprofen Test 8.75 MG, Flurbiprofen Reference 8.75 MG
- Keywords
- flurbiprofen, lozenge, Strepfen, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurbiprofen Test 8.75 MGDrug
Subjects will be asked to swallow saliva before dosing. For each administration, subjects will move the lozenge around in their mouth, suck on the lozenge continually for 15 min and swallow saliva at any time during the product administration procedures, being very careful not to swallow the lozenge.
Flurbiprofen Reference 8.75 MGDrug
Also called Strepfen
Subjects will be asked to swallow saliva before dosing. For each administration, subjects will move the lozenge around in their mouth, suck on the lozenge continually for 15 min and swallow saliva at any time during the product administration procedures, being very careful not to swallow the lozenge.
| Study group | Role | What they receive |
|---|---|---|
| Flurbiprofen 8.75 mg | Experimental | Flurbiprofen 8.75 mg lemon and honey flavour lozenge Receives: Drug: Flurbiprofen Test 8.75 MG |
| Strepfen 8.75 mg | Active comparator | Strepfen 8.75 mg lemon and honey lozenge Receives: Drug: Flurbiprofen Reference 8.75 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration
to evaluate the rate (Cmax) of absorption of flurbiprofen in plasma after single dose administration
Measured: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Area under the plasma concentration-time curve 0-t
to evaluate the extent of absorption of flurbiprofen in plasma after single dose administration
Measured: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Secondary outcomes (5)
Time to achieve Cmax
to evaluate time to achieve Cmax
Measured: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
tlag
to evaluate time prior to the first measurable (i.e. above lower quantification limit) concentration
Measured: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Relative bioavailability of flurbiprofen in plasma
to evaluate relative bioavailability of flurbiprofen in plasma
Measured: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Palatability
to assess the palatability of test and reference formulations using a 0-100 mm VAS where 0 mm indicated "not pleasant at all" and 100 mm indicated "very pleasant".
Measured: 2 times through the two week study period
Treatment-Emergent Advers Events
to evaluate number of TEAEs and number of subjects with TEAEs
Measured: through the two week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start19 Jun 2018
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Single dose, open-label, randomised, 2-way cross-over bioequivalence study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, Cross Research S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670601
- Sponsor's protocol ID
- 073WO18070
- Other IDs
- CRO-PK-18-329
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Flurbiprofen 8.75 mg Lozenge vs. the Reference Product Strepfen 8.75 mg Lozenge in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04670601
- Acronym / sponsor ID
- 073WO18070
- Conditions
- Healthy
- Keywords
- flurbiprofen, lozenge, Strepfen, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 17 Dec 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.
The present study has been designed to compare flurbiprofen pharmacokinetic profile after administration of flurbiprofen 8.75 mg lozenges, marketed by ACRAF, S.p.A., Italy (test product), and the marketed Strepfen 8.75 mg honey and lemon lozenges reference product. (Reckitt Benckiser Portugal SA).
Detailed description
This is a single dose, open-label, randomised, 2-way cross-over bioequivalence study aimed to compare the bioavailability and the plasma pharmacokinetic profile of flurbiprofen after single dose administration of test and reference formulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single dose, open-label, randomised, 2-way cross-over bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Flurbiprofen 8.75 mg | Experimental | Drug: Flurbiprofen Test 8.75 MGFlurbiprofen 8.75 mg lemon and honey flavour lozenge |
| Strepfen 8.75 mg | Active comparator | Drug: Flurbiprofen Reference 8.75 MGStrepfen 8.75 mg lemon and honey lozenge |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Informed consent: signed written informed consent before inclusion in the study.
- Sex and Age: males and females, 18-55 years old inclusive.
- Habits: non smokers.
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
- Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position.
Key exclusion criteria (13 listed)
- Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities.
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; subjects with dry mouth conditions or with any other diseases/problems of the mouth which the investigator considers may affect the outcome of the study.
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study.
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 |
|---|---|---|
| Flurbiprofen Test 8.75 MGSubjects will be asked to swallow saliva before dosing. For each administration, subjects will move the lozenge around in their mouth, suck on the lozenge continually for 15 min and swallow saliva at any time during the product administration procedures, being very careful not to swallow the lozenge. | Drug | Flurbiprofen 8.75 mg |
| Flurbiprofen Reference 8.75 MGAlso: StrepfenSubjects will be asked to swallow saliva before dosing. For each administration, subjects will move the lozenge around in their mouth, suck on the lozenge continually for 15 min and swallow saliva at any time during the product administration procedures, being very careful not to swallow the lozenge. | Drug | Strepfen 8.75 mg |
Primary outcome
Maximum Plasma Concentration
Time frame: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
to evaluate the rate (Cmax) of absorption of flurbiprofen in plasma after single dose administration
Area under the plasma concentration-time curve 0-t
Time frame: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
to evaluate the extent of absorption of flurbiprofen in plasma after single dose administration
5 secondary outcomes
Time to achieve Cmax
Time frame: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
tlag
Time frame: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Relative bioavailability of flurbiprofen in plasma
Time frame: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Palatability
Time frame: 2 times through the two week study period
Treatment-Emergent Advers Events
Time frame: through the two week study period
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 17 Dec 2020.
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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.
Milko Radicioni, MD principal investigator
Cross Research S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flurbiprofen Test 8.75 MG and Flurbiprofen Reference 8.75 MG in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
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 12 inclusion and 13 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 17 Dec 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 Switzerland. 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?
Maximum Plasma Concentration (time frame: pre-dose (0), 10, 20, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose). 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?
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 17 Dec 2020.