| To estimate the Bioavailability of CANSSUFIVE® Nuvastatic in healthy adult Male Human Subjects. | For SAD study:An open label, randomized, single period, single ascending dose to establish the bioavailability parameters of the formulation, CANSSUFIVE® Nuvastatic (C5OSEW5050ESA), composed of standardized extract of Orthosiphon stamineus in 48 healthy, adult, male human subjects under fasting conditions.For MAD study:An open label, randomized, single period, multiple ascending dose to establish the bioavailability parameters of the formulation, CANSSUFIVE® Nuvastatic (C5OSEW5050ESA), composed of standardized extract of Orthosiphon stamineus in 32 healthy, adult, male human subjects under fasting conditions.For cross over study:An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose oral bioequivalence study of formulation, CANSSUFIVE® Nuvastatic (C5OSEW5050ESA), composed of standardized extract of Orthosiphon stamineus in tablet and powder forms in 24 healthy, adult, male human subjects under fasting conditions. - NRPL-056-CANS-16 | CTRI/2017/09/009645 |
