ISRCTN64925094已完成1 期
Bioequivalence study of a new ramipril 10 mg/furosemide 25 mg hard capsule fixed dose combination (Neopharmed Gentili S.p.A.) versus a free combination of ramipril 10 mg tablets (Triatec®, Sanofi-Aventis) and furosemide 25 mg tablets (Lasix®, Sanofi-Aventis) in healthy male and female volunteers under fasting conditions
eopharmed Gentili S.p.A.0 个研究点目标入组 48 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
- 48
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: males/females, 18 - 55 year old inclusive
- •3. Body Mass Index: 18.5 - 28 kg/m² inclusive
- •4. Vital signs: systolic blood pressure 100 - 139 mmHg, diastolic blood pressure 60 - 89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- •5. Body temperature: 35.7 - 37.5° C at screening
- •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): 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
- •Female participants of non-child-bearing potential or in post-menopausal status for at least one year will be admitted.
- •For all women, pregnancy test result must be negative at screening and Day -1.
排除标准
- •1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities
- •2. Physical findings: clinically significant abnormal physical findings indicative of physical illness
- •3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- •4. Virology: positive result of serum virology assays
- •5. Allergy: ascertained or presumptive hypersensitivity to the active principles 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
- •6. Hypotension and heart rate: during the screening procedures or history of orthostatic hypotension or syncope/fainting or heart rate <50 bpm
- •7. Diseases: significant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological, psychiatric and in particular gastrointestinal diseases that may interfere with the aim of the study. History of heart failure. Raynaud's syndrome. Events of haemorrhage (e.g. epistaxis) for 90 days before the day of screening
- •8. Medications: any medications, including over the counter medications, herbal remedies and vitamins for 2 weeks before the start of the study. Organ-toxic drugs (e.g. any drug with a well-defined potential for toxicity to a major organ or system such as chloramphenicol, which may cause bone marrow suppression) and systemic drugs known to alter hepatic metabolism within 3 months before first dosing. Any prescription systemic treatment within 28 days before first dosing. Hormonal contraceptives for women will be allowed.
- •9. 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
- •10. Blood donation: blood donations for 3 months before this study
- •11. 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)
- •12. Drug test: positive result at the drug test at screening
- •13. Alcohol test: positive alcohol breath test at Day -1
- •14. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •15. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
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