Status:
COMPLETED
Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief Summary
Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02191787
Start Date
March 1 1998
Last Update
July 17 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.