Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2018-06-19
2018-07-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Flurbiprofen 8.75 mg
Flurbiprofen 8.75 mg lemon and honey flavour lozenge
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.
Strepfen 8.75 mg
Strepfen 8.75 mg lemon and honey 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Cross Research S.A.
INDUSTRY
Aziende Chimiche Riunite Angelini Francesco S.p.A
INDUSTRY
Responsible Party
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Principal Investigators
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Milko Radicioni, MD
Role: PRINCIPAL_INVESTIGATOR
Cross Research S.A.
Locations
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CROSS Research S.A., Phase I Unit
Arzo, , Switzerland
Countries
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Other Identifiers
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CRO-PK-18-329
Identifier Type: OTHER
Identifier Source: secondary_id
073WO18070
Identifier Type: -
Identifier Source: org_study_id