Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Seresis®; Drug: Placebo

• Registration Number: NCT02191787
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Primary Completion: 1998-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seresis® + Placebo	Placebo	2 capsules Seresis® o.d. for 5 days 2 capsules Placebo o.d. the day before treatment with Seresis®
Seresis® + Placebo	Seresis®	2 capsules Seresis® o.d. for 5 days 2 capsules Placebo o.d. the day before treatment with Seresis®

Primary Outcome Measures

Name	Time	Method
Changes in total antioxidant activity of Seresis®	Baseline, Day 2	determined by chemoluminescence

Secondary Outcome Measures

Name	Time	Method
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
Changes in total antioxidant activity of Seresis®	Day 2, day 6	determined by chemoluminescence