The main purpose of this study is to compare the pharmacokinetics (how the body absorbs and clears the drug) and evaluate the bioequivalence of two formulations of sitagliptin/metformin hydrochloride extended-release tablets (50 mg/500 mg) in healthy adult subjects. The test product is manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd., and the reference product is Janumet® XR. The study is designed as a single-center, open-label, randomized, single-dose, two-period, two-sequence crossover trial. It consists of two separate parts: a fasting study and a fed study. Participants will be randomly assigned to receive either the test formulation or the reference formulation in the first period. After a washout period of at least 5 days, participants will receive the alternate formulation in the second period. Blood samples will be collected at designated time points before and after dosing to measure the blood concentration of sitagliptin and metformin. Safety will also be continuously monitored throughout the study by assessing adverse events, vital signs, electrocardiograms (ECGs), and clinical laboratory tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
76
A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd., administered with 240 mL of warm water.
A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet (Janumet XR) manufactured by Merck Sharp \& Dohme Corp., administered with 240 mL of warm water.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Maximum Observed Plasma Concentration (Cmax) of Sitagliptin and Metformin
Cmax will be obtained directly from the observed plasma concentration-time profiles of sitagliptin and metformin.
Time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Sitagliptin and Metformin
AUC0-t is calculated using the linear trapezoidal rule.
Time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infty) of Sitagliptin and Metformin
AUC0-infty is calculated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.
Time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
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