A Randomized, Double‐Blind, Two‐Treatment, Two‐Period, Crossover Study Investigating the Systemic Bioavailability of a Novel Cocrystal Ubiquinol Formulation Compared with a Ubiquinone Formulation in Healthy Adults

TL;DR

This study shows that a new ubiquinol formulation has better absorption in the body than a traditional ubiquinone formulation in healthy adults.

Contribution

The study introduces a novel cocrystal ubiquinol formulation with significantly higher systemic bioavailability compared to ubiquinone.

Findings

The test ubiquinol formulation showed 2.20 times higher peak plasma concentration than the ubiquinone reference.

The ubiquinol formulation had 2.01 times higher AUC0–t and 3.43 times higher AUC0–∞ compared to ubiquinone.

No adverse events were reported for either formulation in the small pilot study.

Abstract

Coenzyme Q10 (CoQ10) is a naturally occurring biochemical cofactor found in all human cell membranes in two interconvertible forms: oxidized ubiquinone and reduced ubiquinol. Clinical studies indicate that different CoQ10 formulations have different absorption rates, highlighting research comparing their systemic bioavailability. This study compared the oral bioavailability of cocrystal formulation soft gels (test product), a novel ubiquinol formulation, and ubiquinone formulation (reference product) in a randomized, double‐blind, two‐period crossover study with 12 healthy subjects under fasting conditions. The secondary objective of this study was to evaluate the safety and tolerability of the ubiquinol formulation. The pharmacokinetic analyses indicated that the test ubiquinol formulation demonstrated substantially higher relative systemic bioavailability compared with the ubiquinone reference. The geometric mean ratios (test/reference) for baseline‐corrected peak plasma concentration (Cmax) and area under the curve from zero to last quantifiable time (AUC0–t) were 2.20 and 2.01, respectively, with 90% confidence intervals of 1.59–3.04 and 1.51–2.70. The geometric mean ratio for AUC from time zero to infinity (AUC0–∞) was 3.43 (90% CI: 1.47–8.00). No adverse events were reported in this small pilot study for either of the formulations. These findings demonstrate that ubiquinol has a better systemic bioavailability than ubiquinone, supporting the novel formulation's potential as a promising alternative to traditional CoQ10 supplements.

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