ISRCTN95265400已完成1 期
Bioavailability study of a mesalazine formulation of 1200 mg gastro-resistant prolonged-release tablets versus the marketed product Mesavancol® administered to healthy volunteers under fed conditions
Mogon Pharmaceuticals Sagl0 个研究点目标入组 16 人开始时间: 2023年8月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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 (<1600 or >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.
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