Type2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Three Dose Levels of the Investigational Drug (PB-201) in Drug-naive Adult Subjects With Type 2 Diabetes Mellitus as Monotherapy
This crossover study investigates the safety, tolerability, pharmacokinetics (PK)
,pharmacodynamics (PD) effect of three dose levels of PB-201,and characterizes the PK profile
of a prominent des-methyl metabolite of PB-201(WI-0800), following dosing of three dose
levels of PB-201 in drug-naive Chinese adult subjects with Type 2 diabetes mellitus (T2DM) as
monotherapy.
There were 7 days separating 4 treatment periods and at least 7-day washout (but not
exceeding 14 days) between dosing in 4 periods with 3 dose levels of PB-201 and placebo.
Three dose levels of PB-201 are: split dose regimen of 50 mg 30 minutes before morning meal
plus 50 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split
dose regimen of 100 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at
approximately 3.5 hours after morning dose, and split dose regimen of 150 mg 30 minutes
before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after
morning dose.
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