A BIOEQUIVALENCE STUDY OF COENZYME Q10
IN HEALTHY SUBJECTS
Affiliations: Huntington Study Group
Sponsorship: High Q Foundation
Background: Coenzyme Q10 (CoQ10) is a naturally occurring compound with possible neuropro-tective effects that has been under investigation in neurodegenerative conditions such as Parkin-son’s disease and Huntington’s disease. As CoQ10 is currently classified as a dietary supplement, it does not have to meet the same FDA standards as prescription medications. Numerous formu-lations are available, with differing claims of bioavailability and purity.
Objectives: To examine plasma concentrations of CoQ10 in response to a single oral dose of medication. Plasma concentrations achieved over a 48-54 hour period from four different formu-lations were compared. The formulations were also assayed for potentially harmful excipients and the amount of active CoQ10.
Methods: The subjects enrolled in a 60-day protocol. The order of administration of CoQ10 for-mulations was randomized. Subjects received a single 600mg dose of a CoQ10 formulation, and had serial blood draws performed pre-dose and at .5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24-30 and 48-54 hours post-dose. Subjects then underwent a two-week washout period, with the process being repeated for each of the other three formulations. CoQ10 formulations used in the trial were sent for assay to measure the amount of active compound and the excipients ethylene glycol and pro-pylene glycol. Formulations used in this study included two chewable wafers (one with 300 IU of Vitamin E, and one without), one hard gelatin capsule, and one gelcap containing an oil-based vehicle.
Results: Of the 25 subjects enrolled in the study. 24 completed the study with one subject with-drawing because of difficulty obtaining venous access. No serious adverse events were recorded during the trial. Of the 10 adverse events in the trial, all were thought unrelated or unlikely re-lated to study drug. Review of the blood draws did not reveal any major differences in plasma CoQ10 curves generated by the different CoQ10 formulations. Assay of the preparations revealed that all contained the claimed amount of CoQ10. All products had < 3µg of ethylene glycol and < 4µg of propylene glycol, save for the chewable tablet with Vitamin E which contained < 10µg of ethylene glycol and 586 µg of propylene glycol.
Conclusions: Plasma concentration curves generated by CoQ10 formulations studied did not re-veal any major differences between the preparations. Each preparation led to substantive (>50%) increase in mean plasma levels.
Presented at The Movement Disorders Society meeting
in New Orleans,
LA 03/06/2005
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