ISRCTN72651199已完成1 期
Effect of food on diclofenac pharmacokinetics after administration of diclofenac epolamine (DHEP) tablets to healthy volunteers
IBSA Institut Biochimique (Switzerland)0 个研究点目标入组 20 人开始时间: 2020年11月16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
- 20
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. Age 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. 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
- •6. Contraception and fertility (women): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
- •6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- •6.2. 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
- •6.3. A male sexual partner who agrees to use a male condom with spermicide
- •6.4. A sterile sexual partner
- •7. Female participants of non-childbearing potential or in post-menopausal status for at least one year will be admitted
- •8. For all women, pregnancy test result must be negative at screening and Day -1
排除标准
- •1. Electrocardiogram: 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 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
- •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
- •6. Medications: medications, including over the counter medications, herbal remedies and supplements for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapy 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
- •11. Alcohol test: positive alcohol breath test at 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 (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
研究者
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