Bioequivalence of Flurbiprofen Lozenge vs Strepfen

NCT04670601 | Completed Phase 1

• 2 other identifiers: 073WO18070CRO-PK-18-329
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Keywords

flurbiprofen; lozenge; Strepfen; bioequivalence

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration

  to evaluate the rate (Cmax) of absorption of flurbiprofen in plasma after single dose administration

  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

  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

  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

  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

  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

  2 times through the two week study period

• Treatment-Emergent Advers Events

  through the two week study period

Study Arms (2)

Flurbiprofen 8.75 mg

EXPERIMENTAL

Flurbiprofen 8.75 mg lemon and honey flavour lozenge

Drug: Flurbiprofen Test 8.75 MG

Strepfen 8.75 mg

ACTIVE COMPARATOR

Strepfen 8.75 mg lemon and honey lozenge

Drug: Flurbiprofen Reference 8.75 MG

Interventions

Flurbiprofen Test 8.75 MG DRUG

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 8.75 mg

Flurbiprofen Reference 8.75 MG DRUG

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.

Also known as: Strepfen

Strepfen 8.75 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Cross Research S.A.: collaborator

Study Sites (1)

CROSS Research S.A., Phase I Unit

Arzo, CH-6864, Switzerland

Location

MeSH Terms

Interventions

strepfen

Study Officials

• Milko Radicioni, MD

  Cross Research S.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose, open-label, randomised, 2-way cross-over bioequivalence study

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: June 19, 2018
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

CH (1)