Oral repeated-dose toxicity studies of coenzyme Q10 in beagle dogs.

ABSTRACT: To support phase III testing of coenzyme Q10 (CoQ??) in humans, we conducted pharmacokinetic and toxicology studies in beagle dogs. Following single gavage administration of CoQ?? at 600, 1200, 1800, or 2400 mg/kg per d no obvious dose response was observed in maximum concentration (C(max)) or area under the curve (AUC) versus time curve at the 3 highest dosages. In a repeated-dose study of CoQ?? at 600, 1200, 1800, or 2400 mg/kg per d for 4 weeks, CoQ?? reached steady state in plasma by 2 weeks at all dosages. Both C (max) and AUC increased with increasing dosage of CoQ??. The highest plasma levels were recorded at 1800 mg/kg per d. In a 39-week chronic toxicity study of CoQ?? at 1200 and 1800 mg/kg per d or placebo, CoQ?? reached steady state in plasma by 13 weeks. Behaviors, blood chemistries, and detailed histopathology were normal. No deaths occurred. These results support the use of a 2400 mg/d dosage of CoQ?? in human clinical trials.

SUBMITTER: Yerramilli-Rao P 

PROVIDER: S-EPMC3288259 | biostudies-literature | 2012 Jan-Feb

REPOSITORIES: biostudies-literature