Chronic inflammation of the intestinal epithelium Digestive System
Conditions
Interventions
A single oral dose of Mesalazine 1200 mg gastro-resistant prolonged-release tablets and Mesavancol® 1200 mg gastro-resistant prolonged-release tablets will be administered under fed conditions in 2 su
Sponsors
Mogon Pharmaceuticals Sagl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled in this study, subjects must fulfil all the following criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: males/females, 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. Salicylates drugs: intake of salicylates drugs (such as aspirin) at least once in life without any allergic reactions 6. Full comprehension: the ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study 7. Contraception and fertility (females only): females of child-bearing potential must be using at least one of the following reliable methods of contraception: 7.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 7.2. 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 7.3. A male sexual partner who agrees to use a male condom with spermicide 7.4. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, pregnancy test results must be negative at screening and on day -1.
Exclusion criteria
Exclusion criteria: Subjects meeting any of these criteria will not be enrolled in the study: 1. Electrocardiogram (ECG, 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, salicylates, aminosalicylates, formulations ingredients or related drugs (sulfasalazine); 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. Known renal dysfunction 6. Medications: medications, including over-the-counter medications and herbal remedies, in particular aspirin and other salicylates, nephrotoxic agents including non-steroidal anti-inflammatory drugs, azathioprine, 6-mercaptopurine and coumarin-type anticoagulants e.g., warfarin, for 2 weeks before the start of the study. Hormonal contraceptives for females 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 females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2020-2025], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day) 10. Drug test: a positive result at the drug test at screening 11. Alcohol test: positive alcohol test on 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 (females only): positive or missing pregnancy test at screening or on day -1, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from administration to the last observed concentration time t (AUC0-t) and maximum plasma concentration (Cmax) of mesalazine (5-ASA) calculated from the concentrations of plasma samples taken at pre-dose (0) and 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 28, 36, 48, 60 and 72 h post-dose after single dose administration of the two treatments (Mesalazine 1200 mg gastro-resistant prolonged release tablets and the Mesavancol® 1200 mg gastro-resistant prolonged release tablets) under fed conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to peak (tmax), relative bioavailability (Frel) and, if feasible, area under the concentration-time curve extrapolated to infinity (AUC0-inf), half-life (t1/2) and percentage of the residual area extrapolated to infinity in relation to the total AUC0-inf (%AUCextra) of mesalazine (5-ASA) after single-dose administration of the two treatments (Mesalazine 1200 mg gastro-resistant prolonged-release tablets and the Mesavancol® 1200 mg gastro-resistant prolonged-release tablets) under fed conditions 2. All adverse events occurring after the informed consent signature but before (PTAEs) or after (TEAEs) the first dose of the investigational medicinal product, vital signs (blood pressure and heart rate, measured at the screening visit, on Day 1 of each study period at pre-dose (0) and at 10 h post-dose, on Day 4 of each study period at 72 h post-dose and at early termination visit [ETV] as applicable), body weight (measured at screening and final visit/ETV as applicable), physical examination (performed at screening and final visit/ETV as applicable), clinical laboratory parameters (haematology, blood chemistry and urine analysis performed at screening and final visit/ETV as applicable; virology performed at screening; urine drug test performed at screening; a serum pregnancy test at screening; urine pregnancy test at the entrance of each study period). | — |
Countries
Switzerland
Outcome results
None listed