Tier 3 — preclinical

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

Xuefeng Mei, Bingqing Zhu, Kshitij Soni, Kishore Kasaraneni, Nirav Panchal
Clinical Pharmacology in Drug Development 2026 15(3):e70042

Bibliography

PubMed
PMID 41789786
PubMed Central
PMC12965043
DOI
10.1002/cpdd.70042
Funding
Funded/supported by Cocrystal Health Industry Co., Ltd.
Competing interests
The authors declared no conflicts of interest, but one author was affiliated with Cocrystal Health Industry Co., Ltd., the company associated with the proprietary cocrystal ubiquinol formulation. This commercial affiliation is relevant to interpretation.

Study snapshot

DesignRandomized, double-blind, two-treatment, two-period crossover pharmacokinetic study under fasting conditions.
ModelHealthy adults aged 45–65 years.
Sample12 participants: 6 men and 6 women; all completed both periods.
InterventionCocrystal ubiquinol softgel 240 mg total (2 × 120 mg) versus ubiquinone reference softgel 240 mg total (2 × 120 mg).
DurationSingle-dose crossover with serial pharmacokinetic sampling through 48 hours in each period.
EndpointsBaseline-corrected Cmax; Baseline-corrected AUC0-t; AUC0-inf; Tmax; Safety and tolerability

What the study showed, in plain terms

This 2026 crossover trial compared equal 240 mg doses of a proprietary cocrystal ubiquinol formulation and a ubiquinone reference in 12 healthy adults. Each participant received both products in separate periods, which minimizes between-person variability.

Baseline-corrected Cmax averaged 1.041 ± 0.585 µg/mL with cocrystal ubiquinol versus 0.486 ± 0.314 with the ubiquinone reference. The geometric-mean ratio was 2.20 (90% CI 1.59–3.04). AUC0–t was also higher, with a test/reference ratio of 2.01 (90% CI 1.51–2.70); AUC0–inf ratio was 3.43 (90% CI 1.47–8.00).

No adverse events were reported. The correct interpretation is narrow: this specific cocrystal ubiquinol product produced higher systemic exposure than this specific ubiquinone reference under the study conditions. It does not prove that every ubiquinol product is twice as bioavailable as every ubiquinone product.

Key findings

  • Cmax: 1.041 ± 0.585 µg/mL cocrystal ubiquinol vs 0.486 ± 0.314 ubiquinone reference.
  • Cmax geometric-mean ratio test/reference: 2.20 (90% CI 1.59–3.04).
  • AUC0–t geometric-mean ratio: 2.01 (90% CI 1.51–2.70).
  • AUC0–inf geometric-mean ratio: 3.43 (90% CI 1.47–8.00), with a wide confidence interval.
  • All 12 participants completed both periods and no adverse events were reported.

What this study can and cannot tell us

  • Only 12 participants; pharmacokinetic estimates, especially AUC0–inf, are imprecise.
  • Single-dose fasting study; fed-state and long-term exposure may differ.
  • The test was one proprietary cocrystal formulation; the result cannot be generalized to generic ubiquinol as a chemical class.
  • Commercial funding/affiliation is directly relevant to this comparative formulation claim.
  • No clinical efficacy outcomes were assessed.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology