PHARMACOKINETIC STUDY OF ASHWAGANDHAQA™ VERSUS A STANDARD ASHWAGANDHA ROOT EXTRACT IN HEALTHY HUMANS: A RANDOMIZED, DOUBLE-BLIND, CROSSOVER, SINGLE-DOSE STUDY

Objective: To evaluate the single-dose pharmacokinetic profile and relative bioavailability of total withanolides from AshwagandhaQA™, compared to a standard Ashwagandha root extract with 2.5% withanolides respectively Methods: Randomized, double-blind, crossover, single-dose study in 16 healthy adult males under fasting conditions. Subjects received a single oral dose of 500 mg of each extract in random order with a suitable washout period. Plasma concentrations of total withanolides were measured by validated LC-MS/MS over 24 hours. Results: AshwagandhaQA™ (Greenspace Herbs) showed superior bioavailability. Mean (±SE) pharmacokinetic parameters for total withanolides: Cmax 86 ± 6.7 ng/mL, Tmax 2.5 ± 0.2 h, AUC₀₋∞ 1,261 ± 241 ng·h/mL, t½ 7.3 ± 0.29 h, MRT 12.4 ± 0.49 h. Comparable profiles for individual withanolides were observed, with markedly higher exposure than the standard extract. No serious adverse events occurred. Conclusion: AshwagandhaQA™ provides markedly enhanced and sustained exposure of bioactive withanolides compared to a standard 2.5% root extract, supporting its superior performance and once-daily dosing in clinical applications.