The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
21
hard capsules, 100 mg
soft-gel capsules, 100 mg
syrup, 100 mg
MEDEDUS, Ljubljana, Slovenia
Ljubljana, Slovenia
Nutrition Institute, Ljubljana
Ljubljana, Slovenia
Vizera d.o.o., Ljubljana, Slovenia
Ljubljana, Slovenia
improved single dose bioavailability of IP (in comparison to SP)
Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.
Time frame: 48 hours
improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.
Time frame: 14 days
comparable single dose bioavailability of IP (in comparison to CP)
Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.
Time frame: 48 hours
comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.
Time frame: 14 days
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hard capsules, 100 mg - 14 days
soft-gel capsules, 100 mg - 14 days
syrup, 100 mg - 14 days