The effect of food on the proportion of chondroitin sulfate that enters the blood after Condrosulf® tablets are taken in healthy male and female volunteers

Phase 1

Completed

• Conditions: Food effect study in healthy volunteers; Not Applicable

• Registration Number: ISRCTN12755883
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-14
• Study Start: 2022-06-03
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Signed written informed consent before inclusion in the study
2. Men and women aged 30-65 years inclusive
3. Body mass index (BMI) of 18.5-30 kg/m2 inclusive
4. 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. 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 only): 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. Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, pregnancy test result must be negative at screening.

Exclusion Criteria

1. Electrocardiogram (ECG 12-leads, supine position) shows clinically significant abnormalities
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. Ascertained or presumptive hypersensitivity to the active principle (chondroitin sulfate) and/or formulations' ingredients or 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 medications, herbal remedies and food supplements containing chondroitin sulfate for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed.
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 donations for 3 months before this study
9. History of drug, alcohol (>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2020-2025), caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day)
10. Positive result in drug test at screening or Day -3
11. Positive alcohol breath test at Day -3
12. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study or vegetarians;
13. Pregnancy (women only): positive or missing pregnancy test at screening or Day -3 or pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chondroitin sulfate Cmax, AUC0-t and AUC0-8 calculated from levels measured using a fully validated analytical LC-MS/MS method in blood collected on Day -2 and Day -1 at 8:00 ±1 h, 13:00 ±1 h, 20:00 ±1 h and on Days 1, 2 and 3 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 h post-dose