Study to assess the amount of drug that reaches the blood circulation of two new tablets containing mesalazine in comparison with the tablet on the market called Lialda, in healthy volunteers in fasting conditions

Phase 1

Completed

• Conditions: Mild to moderate ulcerative colitis; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN92651188
• Lead Sponsor: DPL Pharma S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-15
• Study Start: 2021-05-18
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: men and women, 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: 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
7. Contraception and fertility (women only): women 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
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 at each scheduled evaluation

Exclusion Criteria

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 products, 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 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 (all study periods)
11. Alcohol test: positive alcohol breath test at day -1 (all study periods)
12. Diet: abnormal diets (<1600 or >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 (all study periods), pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified