ISRCTN17991855已完成1 期
Pharmacokinetics and safety study of Condrosulf® 800 mg tablets after single and multiple doses in healthy male and female volunteers.
IBSA Institut Biochimique (Switzerland)0 个研究点目标入组 18 人开始时间: 2022年6月22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. Signed written informed consent before inclusion in the study
- •2. Men or women aged between 30 and 65 years old inclusive
- •3. Body Mass Index between 18.5 and 30 kg/m2 inclusive
- •4. Vital signs measured after 5 min at rest in the sitting position:
- •4.1. Systolic blood pressure (SBP) 100-139 mmHg
- •4.2. Diastolic blood pressure (DBP) 50-89 mmHg
- •4.3. Heart rate 50-90 bpm,
- •5. Able 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. 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 (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
- •6.3. A male sexual partner who agrees to use a male condom with spermicide
- •6.4. A sterile sexual partner
- •7. Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted
- •8. For all women, pregnancy test results must be negative at screening
排除标准
- •1. Clinically significant abnormalities on 12-leads (supine position) electrocardiogram (ECG)
- •2. Clinically significant abnormal physical findings which could interfere with the objectives of the study
- •3. Clinically significant abnormal laboratory values indicative of physical illness
- •4. Known or presumed hypersensitivity to the active principle (chondroitin sulfate) 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. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine or neurological diseases that may interfere with the aim of the study
- •6. Medications, including over-the-counter (OTC) medications, herbal remedies, and food supplements containing chondroitin sulfate for 2 weeks before the start of the study
- •7. 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 for 3 months before this study
- •9. History of drugs, alcohol (>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025), caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day)
- •10. Positive result at the drug test at screening or day-3
- •11. Positive alcohol breath test on day -3
- •12. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •13. Positive or missing pregnancy test at screening or day -3, pregnant or lactating women
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