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.
Level 2 - randomized trial
Randomized double-blind crossover trial in healthy volunteers
PubMed 41789786 · doi:10.1002/cpdd.70042
What was done
A randomized, double-blind, two-treatment, two-period crossover study in 12 healthy adult subjects evaluated the oral bioavailability, safety, and tolerability of a novel cocrystal ubiquinol soft gel formulation (test product) compared with a standard ubiquinone formulation (reference product) under fasting conditions.
What was found
The test ubiquinol formulation showed significantly higher relative systemic bioavailability compared with ubiquinone. The geometric mean ratios (test/reference) for baseline-corrected peak plasma concentration (Cmax) and area under the curve to the last quantifiable time point (AUC0-t) were 2.20 (90% CI: 1.59–3.04) and 2.01 (90% CI: 1.51–2.70), respectively. 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 for either formulation.
Why it matters
These results provide pharmacokinetic evidence that a cocrystal ubiquinol formulation provides approximately double the systemic exposure of standard ubiquinone under fasting conditions.
Limits
The study sample was very small (n=12) and limited to healthy volunteers under fasting conditions, precluding assessment of food effects, long-term safety, clinical outcomes, or generalizability to populations with CoQ10 deficiency or medical conditions.
Cited by
- supports Ubiquinol possesses higher bioavailability compared to ubiquinone, the oxidized form of coenzyme Q10.