A study on healthy volunteers to assess the distribution of chondroitin sulfate in the human body immediately after taking one dose and after taking a dose every day for 14 days
- Conditions
- OsteoarthritisMusculoskeletal Diseases
- Registration Number
- ISRCTN17991855
- Lead Sponsor
- IBSA Institut Biochimique (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method