ISRCTN17559039已完成1 期
Bioequivalence study of a novel ramipril 10 mg/bisoprolol fumarate 5 mg hard capsule fixed dose combination (Neopharmed Gentili S.r.l.) versus a free combination of ramipril 10 mg tablets (Triatec®, Sanofi-Aventis) and bisoprolol fumarate 5 mg filmcoated tablets (Congescor®, Daiichi Sankyo) in healthy male and female volunteers under fasting conditions
eopharmed Gentili S.r.l.0 个研究点目标入组 36 人开始时间: 2019年4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
- 36
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 (BMI): 18.5-28 kg/m2 inclusive
- •4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 60-89 mmHg, heart rate (HR) 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 (females): females of child-bearing potential had to be using at least one of the following reliable methods of contraception:
- •a. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- •b. A non-hormonal intrauterine device [IUD] 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
- •c. A male sexual partner who agrees to use a male condom with spermicide
- •d. 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 result had to be negative at screening.
- •8. Contraception (males): males with partners of childbearing potential had to either be sterile or agree to use one of the following approved methods of contraception from the first study drug administration until at least 45 days after the last administration:
- •a. A male condom with spermicide
- •b. A sterile sexual partner or a partner in post-menopausal status for at least 1 year
- •c. Use by the female sexual partner of an IUD, a female condom with spermicide, a contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- •9. Male subjects had to accept to inform their partners of the participation in the clinical study
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 considered could affect the outcome of the study
- •6. Hypotension and heart rate: during the screening procedures or history of orthostatic hypotension or syncope/fainting or HR<50 bpm
- •7. Diseases: significant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological, psychiatric and in particular gastrointestinal diseases that could 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 (OTC) medications and 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 females were allowed
- •9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was 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 females and >2 drinks/day for males, 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 (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women
- •16. Previous study: participation in previous trials of ramipril/bisoprolol alone or in a fixed dose combination
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