Phase I study in healthy volunteers of both sexes Not Applicable
Conditions
Interventions
All the subjects enrolled in the study receive the same treatment: one dose of the investigational medicinal product (IMP - OKI gola® 1.6% collutorio) administered as mouthwash in 3 rinses, for a tota
Sponsors
Dompé farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: men/women, 18-55 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m² inclusive 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, pulse rate 50-90 bpm and body temperature 35.5-37.5° C, measured after 5 min at rest in the sitting position 5. 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 study 6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device 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 6.3. A male sexual partner who agrees to use a male condom with spermicide 6.4. A sterile sexual partner Women of non-child-bearing potential or in post-menopausal status for at least 1 year are admitted. For all women, pregnancy test result must be negative at screening.
Exclusion criteria
Exclusion criteria: 1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 2. Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen lysine salt or derivatives) and/or formulations' ingredients; known hypersensitivity to non-steroidal anti-inflammatory drugs; history of hypersensitivity to drugs (in particular to ketoprofen) or allergic reactions in general, which the Investigator considers may affect the outcome of the study 3. Diseases: significant history of renal, hepatic, gastrointestinal, respiratory, skin, haematological, endocrine, neurological or cardiovascular diseases that may interfere with the aim of the study; mouth lesions or any other oral mucosa alteration that may interfere with the aim of the study according to the investigator’s opinion 4. Medications: medications, including over the counter drugs (in particular non-steroidal anti-inflammatory drugs), mouthwashes, oral rinses, herbal remedies and food supplements taken 14 days before the start of the study (in any case at least 5 times the half-life of the drug or a minimum of 14 days, whichever is longer), with the exception of paracetamol. Hormonal contraceptives and hormonal replacement therapy for women are allowed 5. 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 6. Blood donation: blood donations for 3 months before this study 7. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for women and >2 drinks/day for men), caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day) 8. SARS-CoV-2 test: positive SARS-CoV-2 test on day -3 or -2 9. Virology: known positive test of Hepatitis B (HBs antigen), Hepatitis C (HCV antibodies), HIV 1/2 (HIV Antigen/Antibodies combo) 10. Drug test: positive result at the drug test at screening 11. Alcohol test: positive alcohol breath test at screening or day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians; vegans 13. Pregnancy (women only): positive or missing pregnancy test at screening or day -1; pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of ketoprofen remaining in the oral cavity after the mouthwash rinses is measured using a fully validated HPLC-UV method. Salivary ketoprofen pharmacokinetic profile is evaluated up to 30 min post dose using the same analytical method. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma ketoprofen pharmacokinetic profile is evaluated up to 30 min post dose using a fully validated HPLC-UV method. 2. Safety and tolerability of the study treatment are evaluated by collecting the adverse events during the whole study, by measuring vital signs (blood pressure and heart rate) at screening and final visit, and by performing a physical examination at screening and final visit. | — |
Countries
Switzerland
Outcome results
None listed