Healthy
Conditions
Brief summary
Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling
Interventions
DRUGSeresis®
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
The subjects to be enrolled are healthy volunteers, defined as follows: * Healthy men or women between 18 and 30 years old * Non-smokers * Fit for work * Having given informed consent and signed the form
Exclusion criteria
* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, hypervitaminosis A, psychic disorder etc.). * Treatment with other drug that might interfere with the evaluation of the safety of the test drug * Known hypersensitivity to any of the ingredients of the study drug * Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive * Drug and alcohol abuse * Participation in another trial * Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are not medical objections) * Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total antioxidant activity of Seresis® | Baseline, Day 2 | determined by chemoluminescence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total antioxidant activity of Seresis® | Day 2, day 6 | determined by chemoluminescence |
| Assessment of tolerability on a 4-point scale | Day 14 | — |
| Number of patients with abnormal changes in laboratory parameters | up to day 14 | — |
| Number of patients with adverse events | up to day 14 | — |
Outcome results
None listed