Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Seresis®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191852

1135.4

Details and patient eligibility

About

Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma

Enrollment

8 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female volunteers between 18 and 30 years
With skin type II or skin type III
BMI < 25
Non-smokers
Volunteers who have given their written informed consent according to Good Clinical Practice (GCP) and local regulations

Exclusion criteria

Any serious disorder that may interfere with her participation to the trial and evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.), and/or treatment with chronic medication
Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
High performance sports
Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV (DSM-IV)
Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine devices (IUDs), sterilisation)
Pregnancy and/or lactation
Known abnormal values of the lab tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
Abnormal values of low density lipoproteins (LDL) and triglycerides (TGL) levels in blood
Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study