Journal of Bioequivalence & Bioavailability

Abstract

Comparative Bioavailability Study of Ultra Q 300 and COQ300 Coenzyme Q10 in Healthy Adults.

SM Rahman, Honey Qureshi, Poorneshwar Sawant, Sunil Kulkarni, Ravindra Mote* and Parikshit Champanerkar

Purpose: In this study, two Coenzyme Q10 (CoQ10) formulations-Ultra Q 300 (test product) and other brand having similar composition (reference product)-were compared for bioavailability in healthy adult volunteers under fasting condition. Evaluating the safety and tolerability of a single oral administration of Ultra Q 300 at a dose of 300 mg was the secondary objective. 

Methods: Fourteen healthy male volunteers between the age range of 18 and 45 participated in an open-label, randomized balanced, two- treatment, two- sequence, two- period, two-way crossover bioavailability research. During a 15-day washout interval in between doses, participants received a single 300 mg dosage of either Ultra Q 300 or other brand having similar composition while fasting. To assess Pharmacokinetic (PK) characteristics, such as Cmax and Tmax, 25 blood samples were taken over an interval of 96 hours after the dose. A validated LC-MS/MS method was used to determine the concentrations of plasma CoQ10. Clinical examinations, vital sign monitoring, adverse event reporting, and laboratory testing were all included in the safety assessments. 

Results: All 14 participants completed the study without protocol deviations or dropouts. The mean Cmax for Ultra Q 300 was 1345.129 ng/mL versus 1181.796 ng/mL for other brand having similar composition, with Ultra Q 300 showing an average 12.93% higher plasma concentration. Tmax ranged from 5.5 to 7.5 hours for both formulations, indicating comparable absorption rates. The 90% confidence interval of 80%-125% consisted of all significant pharmacokinetic parameters, meeting the regulatory standards for bioavailability. No adverse events or safety concerns were reported during the trial. 

Conclusion: Ultra Q 300 demonstrated improved bioavailability over the other brand having similar composition, shown by a higher mean Cmax and similar Tmax, with no additional safety concerns. This suggests a pharmacokinetic advantage and positions Ultra Q 300 as a potentially more effective and safer option for daily Coenzyme Q10 supplementation.

Published Date: 2025-12-31; Received Date: 2025-12-01