Bioequivalence of Flurbiprofen Lozenge vs Strepfen

Healthy Clinical Trial

Official title:

Bioequivalence Study of Flurbiprofen 8.75 mg Lozenge vs. the Reference Product Strepfen 8.75 mg Lozenge in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04670601
• Other study ID #: 073WO18070
• Secondary ID: CRO-PK-18-329
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2018
• Est. completion date: July 15, 2018

Study information

• Verified date: December 2020
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Flurbiprofen Test 8.75 MG
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 MG
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.

Locations

Country	Name	City	State
Switzerland	CROSS Research S.A., Phase I Unit	Arzo

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	Cross Research S.A.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to achieve Cmax	to evaluate 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
Secondary	tlag	to evaluate time prior to the first measurable (i.e. above lower quantification limit) concentration	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	Relative bioavailability of flurbiprofen in plasma	to evaluate 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
Secondary	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".	2 times through the two week study period
Secondary	Treatment-Emergent Advers Events	to evaluate number of TEAEs and number of subjects with TEAEs	through the two week study period