Status:
COMPLETED
Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
FEMALE
18-30 years
Phase:
PHASE1
Brief Summary
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, compare...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02191852
Start Date
June 1 1999
Last Update
July 17 2014
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