Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

July 16, 2014 updated by: Boehringer Ingelheim

Pharmacokinetic-pharmacodynamic Assessment of Seresis® o.d.: an Open, Uncontrolled, Non-randomised Intraindividual Pilot-study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seresis® + Placebo

2 capsules Seresis® o.d. for 5 days

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in total antioxidant activity of Seresis®
Time Frame: Baseline, Day 2
determined by chemoluminescence
Baseline, Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: up to day 14
up to day 14
Assessment of tolerability on a 4-point scale
Time Frame: Day 14
Day 14
Changes in total antioxidant activity of Seresis®
Time Frame: Day 2, day 6
determined by chemoluminescence
Day 2, day 6
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to day 14
up to day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

May 1, 1998

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 1135.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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