NCT06151171

Pharmacokinetics of Different CoQ10 Formulations

Pharmacokinetics of Different CoQ10 Formulations - a Randomized, Double-blind, Single-dose, Crossover Study on the Bioavailability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Factors Group of Nutritional Companies Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coenzyme Q10 Pharmacokinetics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CoQ10	Participants will be randomly and blindly assigned to receive a single dose (200 mg) of one of the preparations (treatments). Fasting blood samples are taken at baseline (t=0) or pre-dose for CoQ10 baseline determination. Participants receive treatment at time zero with a glass of water (\~ 125 mL), along with a standardized breakfast-provided immediately after the dose. Capsules are administered as a single oral dose, with a wash-out period of at least 3-4 weeks between the two Coenzyme Q10 test products. Capillary blood samples are collected at time points 0, 0.5, 1, 2, 3, 4,5, 6, 8, 10, 12, 24, 48- and 72-hours post-dose. A standardized lunch is provided after the 4hr blood sample, as well as a standardized dinner after the 8-h sample. Identical meals are served to all participants on each test day.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2023-11-30
• Last updated: 2023-12-05

Locations

1 site across 1 country: Canada