Bioavailability of Coenzyme Q10
Conditions
Keywords
coenzyme q10, single dose bioavailability, multiple dose bioavailability
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSingle dose intervention with Investigational product (IP)
syrup, 100 mg
DIETARY_SUPPLEMENTMultiple dose intervention with Standard product (SP)
hard capsules, 100 mg - 14 days
DIETARY_SUPPLEMENTSingle dose intervention with Standard product (SP)
hard capsules, 100 mg
DIETARY_SUPPLEMENTSingle dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
DIETARY_SUPPLEMENTMultiple dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg - 14 days
DIETARY_SUPPLEMENTMultiple dose intervention with Investigational product (IP)
syrup, 100 mg - 14 days
Sponsors
Vizera d.o.o.
Valens Int. d.o.o., Slovenija
MEDEDUS, Ljubljana, Slovenia
Institute of Nutrition, Slovenia (Nutris)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject Informed consent form (ICF) is singed * Aged between 65 and 74 years at the time of the signature of ICF * A body mass index between 20 and 29 kg/m2 * 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), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)
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 * Hypotension * Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological 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 |
|---|---|---|
| improved single dose bioavailability of IP (in comparison to SP) | 48 hours | 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. |
| improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP) | 14 days | Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparable single dose bioavailability of IP (in comparison to CP) | 48 hours | Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value. |
| comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP) | 14 days | Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator. |
Countries
Slovenia
Outcome results
None listed