Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

NCT ID: NCT02191787

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31

Brief Summary

Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seresis® + Placebo

2 capsules Seresis® o.d. for 5 days

2 capsules Placebo o.d. the day before treatment with Seresis®

Group Type: EXPERIMENTAL

Seresis®

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Seresis®

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1135.2

Identifier Type: -

Identifier Source: org_study_id