Bioequivalence of Flurbiprofen Lozenge vs Strepfen | NCT04670601

NCT04670601

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
CRO-PK-18-329	Other Identifier	CROSS Research

Status Module

Name	Class
Cross Research S.A.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
tlag	to evaluate time prior to the first measurable (i.e. above lower quantification limit) concentration

Eligibility Module

Eligibility Criteria

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