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OpenTrials
Completed

NCT Number: NCT02191787

Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seresis®

Drug

Placebo

Drug

Primary outcomes

  1. Changes in total antioxidant activity of Seresis®

    Time frame: Baseline, Day 2

    determined by chemoluminescence

Secondary outcomes

  1. Changes in total antioxidant activity of Seresis®

    Time frame: Day 2, day 6

    determined by chemoluminescence

  2. Assessment of tolerability on a 4-point scale

    Time frame: Day 14

  3. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to day 14

  4. Number of patients with adverse events

    Time frame: up to day 14

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1998
First posted
Jul 16, 2014
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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