Clinical trial NCT06151171: Pharmacokinetics of Different CoQ10 Formulations
Official title: Pharmacokinetics of Different CoQ10 Formulations - a Randomized, Double-blind, Single-dose, Crossover Study on the Bioavailability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coenzyme Q10 Pharmacokinetics
Keywords: bioavailability
CoQ10
Ubiquinol
delivery system
pharmacokinetics
Lead sponsor: Factors Group of Nutritional Companies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Isura
First posted: 2023-11-30
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to compare the bioavailability (AUC, Tmax, and Cmax) of different Coenzyme Q10 preparations in healthy adults. Pharmacokinetic parameters of orally ingested CoQ10 such as AUC, Cmax and Tmax, as well as the ratio of reduced CoQ10 levels to total CoQ10 plasma levels (using the AUC) after administration are compared.


Eligibility criteria: Inclusion Criteria:

* Participants are required to meet the following criteria to be eligible for enrollment: male or female aged 21-65 years or older
* Participants must complete an online health questionnaire on their medical history (pregnancy must be excluded) upon study enrolment.
* Voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Unstable medical condition; use of any acute medications during study period.
* Use of Coumadin Warfarin; use of supplements containing Coenzyme Q10, including the intake of any other supplements within 2 weeks of the beginning of the study (except for vitamin D and calcium). The use of any supplements except for vitamin D and calcium, are prohibited for the duration of the study.
* History of serious acute or chronic diseases such as gastrointestinal disorders, liver-, kidney-, cardiovascular, or hematological disease or diabetes; or other diseases; intolerances or food allergies such as gluten (in terms of the standardized meals).
* Using any form of nicotine or tobacco; participation in another investigational study

Primary outcomes:
measure: AUC: (the area under the concentration-time curve) to evaluate the absorption of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
measure: Cmax: (maximum plasma concentration) To evaluate the peak concentrations of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
measure: Tmax: (the time point of maximum plasma concentration) of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
References: