title: A randomized, double-blind, crossover study on the pharmacokinetics of a novel formulation of CoQ₁₀ with pyridoxal 5'-phosphate and phosphatidyl choline.
abstract: The pharmacokinetics of a single 30-mg dose of a novel enteric-coated coenzyme Q10 (CoQ(10)) formulation with pyridoxal 5'-phosphate and phosphatidyl choline (CoQ(10)-P5P-PC) was investigated against two comparators CoQ(10) (NPN 02176955) and CoQ(10) (DIN 02231736) in 21 healthy volunteers, with screening CoQ(10) levels of 0.8 ± 0.2 mg/L. A randomized, double-blind, crossover study was designed with a washout period of 2 weeks between each formulation and blood sampled at 2, 4, 5, 6, 8, 12, 24, 48 and 72 hr postdose. Significantly, higher plasma concentrations were demonstrated for the CoQ(10) (NPN 02176955) formulation at 6 and 8 hr postdose (p = .010 and p = .042, respectively). There were no significant differences between formulations with respect to the area under the curve, AUC((0-72 hr)), or the maximum plasma concentration (C(max)). Total CoQ(10) (T(max)) reached maximum plasma concentrations at 6.4 ± 2.5 hr after supplementation with CoQ(10) (NPN 02176955), 8.0 ± 9.8 hr with CoQ(10)-P5P-PC, and 9.5 ± 9.3 hr with CoQ(10) (DIN 02231736). The estimated elimination half-life (t(1/2)) was 92.3 hr after a single oral dose of CoQ(10)-P5P-PC, 38.2 hr with CoQ(10) (NPN 02176955), and 80.7 hr with CoQ(10) (DIN 02231736). The results suggest that CoQ(10) is available for a longer time in subjects' administered with CoQ(10)-P5P-PC in comparison with the other two formulations studied. There were no significant differences in adverse events, by severity, causality, or organ system. The CoQ(10)-P5P-PC formulation was found to be superior in the t(1/2), and it may be suggested that fewer doses are required to maintain healthy circulatory CoQ(10) levels.
authors.affiliation: KGK Synergize, Inc., London, ON, Canada. mevans@kgksynergize.com
authors.forename: Malkanthi
authors.initials: M
authors.lastname: Evans
authors.forename: Prachi
authors.initials: P
authors.lastname: Sharma
authors.forename: Najla
authors.initials: N
authors.lastname: Guthrie
mesh_terms: D000328:Adult; D019540:Area Under Curve; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D010713:Phosphatidylcholines / Q000493:pharmacokinetics*; D011732:Pyridoxal Phosphate / Q000493:pharmacokinetics*; D014451:Ubiquinone / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics
chemical_list: D004338:Drug Combinations; D010713:Phosphatidylcholines; D014451:Ubiquinone; D011732:Pyridoxal Phosphate; C024989:coenzyme Q10