This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, China
Peak plasma concentration (Cmax)
Time frame: 0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120)
Time frame: 0-120 hours post dose
area under the plasma concentration vs time curve (AUC0-inf)
Time frame: 0-infinity
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time frame: 0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)
Time frame: 0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 26
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