This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1.
Chiglitazar tablet administered as one of the reference treatment at dose level 1.
Metformin extended-release tablet administered as one of the reference treatment at dose level 1.
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Maximum plasma concentration (Cmax)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Time to Maximum Plasma Concentration(Tmax)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Elimination Half-life (t1/2)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Total Clearance (CL/F)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Volume of Distribution during the terminal phase (Vz/F)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Incidence of Adverse Events (AEs)
Time frame: up to Day 11
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Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2.
Chiglitazar tablet administered as one of the reference treatment at dose level 2.
Metformin extended-release tablet administered as one of the reference treatment at dose level 2.