This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study. The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants. The multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
a single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions
a single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal
a single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10
FE Study: Maximum plasma concentration (Cmax)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Time to Maximum Plasma Concentration(Tmax)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Elimination Half-life (t1/2)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Apparent Total Clearance (CL/F)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Apparent Volume of Distribution during the terminal phase (Vz/F)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Multiple-dose PK study: Maximum plasma concentration (Cmax)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: Time to Maximum Plasma Concentration(Tmax)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: steady-state peak concentration (Cmax,ss)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: steady-state time to peak concentration (Tmax,ss)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: under the plasma concentration-time curve at steady state (AUCss)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: trough concentration (Ctrough)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: accumulation ratio (Rac)
Time frame: predose to 72 hours after the last dose (7 consecutive days of dosing)
Incidence of Adverse Events (AEs)
Time frame: up to Day 16
Change from baseline in hematology parameters: white blood cell count, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count , hemoglobin, hematocrit, platelet count
Change from baseline in hematology parameters: white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count (RBC), hemoglobin (Hb), hematocrit (HCT), platelet count (PLT)
Time frame: up to Day 13
Changes from baseline in serum chemistry parameters
Changes from baseline in serum chemistry parameters: fasting blood glucose (FBG), total protein, albumin, total bilirubin, direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), blood urea nitrogen (BUN) or urea, uric acid, creatinine, potassium (K⁺), sodium (Na⁺), chloride (Cl-), creatine kinase (CK)
Time frame: up to Day 13
Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells
Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells (RBCs)
Time frame: up to Day 13
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