The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations
The single-center, randomized, open-label, five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Study will be conducted with single dose CoQ10 to assess bioavailability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
2 capsules - 200 mg total CoQ10
2 softgels - 200 mg total CoQ10
2 softgels - 200 mg total CoQ10
ADM, ambulanta družinske medicine, Ljubljana, Slovenia
Ljubljana, Slovenia
Relative single dose bioavailability (AUC48) of IP (in comparison to SP)
Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value.
Time frame: 72 hours
Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)
Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration.
Time frame: 72 hours
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2 softgels - 200 mg total CoQ10
2 capsules - 200 mg total CoQ10