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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
Consult Med Iasi
Iași, Iasi County, Romania, Romania
Analysis of Pharmacokinetic Property "Area Under the Curve"
\- Area under the curve (microg/ml x h): ≥5 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
Time frame: from day-7 to day 28
Analysis of Pharmacokinetic Property "Cmax"
\- Cmax: ≥0,8 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
Time frame: from day-7 to day 28
Analysis of Pharmacokinetic Property "Tmax"
\- Tmax: ≥3 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
Time frame: from day-7 to day 28
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