Male & Female Healthy Volunteers Clinical Trial
Official title:
Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24
subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which
will be followed by a one week wash-out period and then by a 4 week period of continuous
administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided
in the continuous treatment period into two groups, one group of 12 patients with intake of
100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess
multiple-dose profile of COQUN ORAL FORMULATION.
Patients will have to fast the night before enrolment, for at least 10 hours. Patients will
be requested to fill in a short diary in the multidose phase, on a daily basis, for
confirming the product correct intake, and informing on any experienced adverse event and
eventual medication taken for its solving.
;