NCT02191787

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1998

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

July 14, 2014

Last Update Submit

July 16, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Changes in total antioxidant activity of Seresis®

    determined by chemoluminescence

    Baseline, Day 2

Secondary Outcomes (4)

  • Changes in total antioxidant activity of Seresis®

    Day 2, day 6

  • 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

Study Arms (1)

Seresis® + Placebo

EXPERIMENTAL

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

Drug: Seresis®Drug: Placebo

Interventions

Seresis®DRUG
Seresis® + Placebo
PlaceboDRUG
Seresis® + Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 16, 2014

Study Start

March 1, 1998

Primary Completion

May 1, 1998

Last Updated

July 17, 2014

Record last verified: 2014-07