Bioavailability of Coenzyme Q10
Conditions
Keywords
coenzyme q10, single dose bioavailability
Brief summary
The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSingle dose intervention with Standard product (SP)
2 capsules - 200 mg total CoQ10
DIETARY_SUPPLEMENTSingle dose intervention with Investigational product (IP1)
2 softgels - 200 mg total CoQ10
DIETARY_SUPPLEMENTSingle dose intervention with Investigational product (IP2)
2 softgels - 200 mg total CoQ10
DIETARY_SUPPLEMENTSingle dose intervention with Investigational product (IP3)
2 softgels - 200 mg total CoQ10
DIETARY_SUPPLEMENTSingle dose intervention with Investigational product (IP4)
2 capsules - 200 mg total CoQ10
Sponsors
Vizera d.o.o.
ADM, Ambulanta družinske medicine, Ljubljana, Slovenia
Adrialab d.o.o., Ljubljana, Slovenia
Tishcon Corp., USA
Institute of Nutrition, Slovenia (Nutris)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject Informed consent form (ICF) is singed * Aged between 18 and 65 years at the time of the signature of ICF * A body mass index between 18.5-29.9 kg/m2 * Total blood cholesterol range 3,11 - 6,50 mmol/L (not treated with medications) * Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study * Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study * Consumption of dairy and cereal products (standardised breakfast will include low lactose dairy and bread) * Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling)
Exclusion criteria
* Intake of any prescribed medication within 2 weeks of the beginning of the study * Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium * Pregnancy or planned pregnancy * Breast-feeding mother * Hypotension * Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or haematological disease, diabetes * Gastrointestinal disorders or other serious acute or chronic diseases * Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals) * Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal * Known drug and/or alcohol abuse * Using any form of nicotine or tobacco * Mental incapacity that precludes adequate understanding or cooperation * Participation in another investigational study or blood donation within 3 months prior to or during this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative single dose bioavailability (AUC48) of IP (in comparison to SP) | 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative single dose bioavailability (AUCinf) of IP (in comparison to SP) | 72 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relative single dose bioavailability (AUC48) among all the investigational products | 72 hours | Relative bioavailability among all the investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) 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. |
| Relative single dose bioavailability (AUCinf) among all investigational products | 72 hours | Relative bioavailability among all investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration. |
Countries
Slovenia
Outcome results
None listed