ISRCTN92651188已完成1 期
Bioavailability study of two new mesalazine formulations versus the marketed formulation Lialda® administered to healthy volunteers in fasting conditions
DPL Pharma S.p.A.0 个研究点目标入组 18 人开始时间: 2021年5月18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
- 18
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
- •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
排除标准
- •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
研究者
相似试验
已完成
1 期
A study of a new gastro-resistant prolonged-release mesalazine tablet formulatioChronic inflammation of the intestinal epitheliumDigestive SystemISRCTN95265400Mogon Pharmaceuticals Sagl16
招募中
不适用
In-vivo Bioequivalence study of Mezasa granules with brand drugs (PENTASA Ferring Pharmaceuticals Co, Gremany)Bio equivalence test.IRCT20200105046010N40Koushan Pharmed Pharmaceutical Company24
进行中（未招募）
1 期
Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D). - Mesalazine for the treatment of IBS-DDiarrhoea-predominant irritable bowel syndromeMedDRA version: 14.0 Level: LLT Classification code 10060849 Term: Diarrhoea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2010-018340-14-GBniversity of Nottingham136
招募中
不适用
In-vivo Bioequivalence Test of MODACOLIT SR Granules with brand drug (Ferring Pharmaceuticals Co, Gremany)Bio equivalence test.IRCT20200105046010N50Teb Mofid Nikan Pharmaceutical Co.24
进行中（未招募）
1 期
Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of coloTreatment of symptomatic uncomplicated diverticular colon disease (SUDD)MedDRA version: 20.0Level: PTClassification code 10013538Term: DiverticulitisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-004159-56-ITDIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II820