Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Seresis®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02191787

1135.2

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Seresis® + Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Seresis®