A comparative pharmacokinetics study of Ashwagandha (Withania somnifera) Root Extract sustained-release capsules: an open-label, randomized, two treatment, two-sequence, two period, single-dose crossover clinical study

Background: In this open-label, randomized, balanced, two-treatment, two-sequence, two-period, crossover, single-dose oral comparative pharmacokinetics study, the pharmacokinetics, safety, and tolerability of test product ‘ashwagandha (Withania somnifera)’ root extract sustained release capsule 300 mg (Prolanza™), each containing 15 withanolides (administered dose: 2×15 mg) was compared with that a reference (organic KSM-66 ashwagandha [vegan] capsule, [administered mg]).Methods: Total 14 healthy men were randomized to receive either or as single dose 2 capsules in sequence, administered under fasting conditions. Plasma concentrations total withanolides, withanolide A 12-deoxywithastramonolide measured using validated liquid chromatography–mass spectroscopy/mass spectroscopy.Results: The had higher relative absorption, better bioavailability, longer elimination half-life indicating sustained-release profile reference. Specifically, bioavailability formulation 12, 44, 11 times for 12-deoxywithastramonolide, respectively. No adverse events reported during study.Conclusions: product, will provide more long-lasting therapeutic effects from daily (Retrospectively applied on Clinical Trials Registry - India [CTRI]. Application number: REF/2020/03/032408). study reports unique Withania somnifera (Ashwagandha) extract. pharmacokinetic also first time, successful plasma estimation 12-deoxywithastraamonolide, major phytoactives ashwagandha.