Effect of food on diclofenac pharmacokinetics Not Applicable
Conditions
Interventions
A single dose of the investigational medicinal product (Diclofenac epolamine [DHEP] 65 mg tablet [containing 65 mg of diclofenac epolamine, corresponding to 50 mg of diclofenac sodium]) will be admini
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Age 18 - 55 years old inclusive 3. Body Mass Index: 18.5 - 30 kg/m² inclusive 4. Vital signs: systolic blood pressure 100 - 139 mmHg, diastolic blood pressure 50 - 89 mmHg, heart rate 50 - 90 bpm, 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 entire study 6. Contraception and fertility (women): 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 7. Female participants of non-childbearing potential or in post-menopausal status for at least one year will be admitted 8. For all women, pregnancy test result must be negative at screening and Day -1
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram: 12-leads (supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. 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 5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study 6. Medications: medications, including over the counter medications, herbal remedies and supplements for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapy for women will be allowed 7. 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 8. Blood donation: blood donations for 3 months before this study 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day) 10. Drug test: positive result at the drug test at screening or Day -1 11. Alcohol test: positive alcohol breath test at Day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 13. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability of diclofenac assessed by comparing the rate (Cmax) and extent (AUC0-t) of absorption measured using ... during each condition | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of diclofenac will be evaluated during each condition by 1. Adverse events measured using self-reports and patient records throughout the study 1.1. Pre-treatment AEs (PTAEs) are all AEs occurring after IC signature by the enrolled subject but before the the first dose of IMP 1.2. Treatment-Emergent AEs (TEAEs) are all AEs occurring or worsening after the administration of the first dose of IMP 2. Vital signs (blood pressure [mmHg], heart rate [bpm]) measured at screening visit, day 1of each period: pre-dose (0) and 8 h post-dose and at early termination visit (if applicable) 3. Bodyweight (kg) 4. Physical examinations are performed at the screening and final visit/early termination visit (ETV) to check subjects’ overall health and the occurrence of any AE throughout the study duration 5. Laboratory parameters: 5.1. Haematology, blood chemistry, serum virology and urine analysis is performed at the screening visit 5.2. A urine drug test is performed at the screening and at the entrance of each study period, using a urine multi-drug kit 5.3. A serum pregnancy test is performed by the laboratory at screening. A urine pregnancy test is performed at the entrance of each study period 5.4. Haematology, blood chemistry are performed at the final visit/ETV 6. Heart rate variability and heart activity measured using ECG at screening and final visit/ETV | — |
Countries
Switzerland
Outcome results
None listed