Pharmacokinetic-pharmacodynamic Assessment of Seresis® in... | NCT02191787

Studies
Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

NCT02191787

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 17, 2014Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Seresis®
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1998

Primary Completion Date

May 1998Actual

Completion Date

Not provided

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Jul 14, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2014

Last Update Posted Date

Jul 17, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Seresis®	Drug		Seresis® + Placebo
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Changes in total antioxidant activity of Seresis®	determined by chemoluminescence	Day 2, day 6
Assessment of tolerability on a 4-point scale		Day 14

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided