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Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

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Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: Seresis®

Study type

Interventional

Funder types

Industry

Identifiers

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)

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®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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