Tier 3 — preclinical

Study on safety and bioavailability of ubiquinol (Kaneka QH) after single and 4-week multiple oral administration to healthy volunteers

Kazunori Hosoe, Mitsuaki Kitano, Hideyuki Kishida, Hiroshi Kubo, Kenji Fujii, Mikio Kitahara
Regulatory Toxicology and Pharmacology 2007 47(1):19-28

Bibliography

PubMed
PMID 16919858
DOI
10.1016/j.yrtph.2006.07.001
Funding
Study conducted by authors from Kaneka Corporation Life Science Research Laboratories using Kaneka QH ubiquinol.
Competing interests
All listed authors were affiliated with Kaneka Corporation, the manufacturer/developer of the tested ubiquinol ingredient.

Study snapshot

DesignSingle-blind placebo-controlled single-dose and four-week multiple-dose human pharmacokinetic/safety studies.
ModelHealthy volunteers.
SampleSingle-dose study: 15 healthy volunteers. Multiple-dose study: 80 enrolled and 78 analyzed.
InterventionSingle-dose ubiquinol 150 or 300 mg; repeated ubiquinol 90, 150 or 300 mg/day for four weeks.
DurationSingle-dose pharmacokinetic study plus four-week multiple-dose study, with follow-up extending two weeks after treatment.
EndpointsCmax; AUC0-48; Trough plasma CoQ10; Laboratory safety; Vital signs; ECG; Physical examination; Adverse events

What the study showed, in plain terms

This early human study evaluated Kaneka QH ubiquinol both as single 150/300 mg doses and as daily 90, 150 or 300 mg doses for four weeks. It was primarily a pharmacokinetic and safety study, not an efficacy trial.

After single doses, Cmax rose from about 1.88 µg/mL at 150 mg to 3.19 µg/mL at 300 mg, while AUC0–48 increased from 74.61 to 91.76 µg·h/mL. During repeated dosing, trough concentrations plateaued by about day 14 at approximately 2.61 µg/mL for 90 mg/day, 3.66 for 150 mg/day and 6.53 for 300 mg/day. Exposure therefore increased nonlinearly with dose.

The investigators reported no clinically relevant changes in laboratory tests, physical examination, vital signs or ECG, and no major safety concern through two weeks after treatment at doses up to 300 mg/day. Because the study was short and entirely manufacturer-affiliated, it supports short-term tolerability and PK—not long-term safety or clinical benefit.

Key findings

  • Single-dose Cmax: approximately 1.88 µg/mL after 150 mg and 3.19 µg/mL after 300 mg ubiquinol.
  • Single-dose AUC0–48: approximately 74.61 versus 91.76 µg·h/mL for 150 versus 300 mg.
  • Day-14 trough plateau: ~2.61 µg/mL at 90 mg/day, 3.66 at 150 mg/day and 6.53 at 300 mg/day.
  • The dose-exposure relationship was nonlinear rather than strictly proportional.
  • No clinically relevant safety changes were reported in laboratory tests, physical examination, vital signs or ECG up to 300 mg/day over four weeks.

What this study can and cannot tell us

  • Four weeks of repeated dosing is insufficient to establish long-term or rare-event safety.
  • Healthy volunteers only; safety in pregnancy, severe chronic disease or complex polypharmacy cannot be inferred.
  • All listed authors were affiliated with Kaneka Corporation and the study tested Kaneka QH, so this is manufacturer-conducted evidence.
  • Pharmacokinetic exposure and tolerability do not demonstrate a clinical health benefit.

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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