Chengdu Hengrui Initiates Bioequivalence Trial for Sitagliptin Phosphate Tablets for Type 2 Diabetes

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that the fasting and postprandial administration trial with a single-center, randomized, open-label, two-period, single-dose, crossover design for Sitagliptin Phosphate Tablets by Chengdu Hengrui Pharmaceutical Co., Ltd. has been initiated. The clinical trial registration number is CTR20254033, and the initial information disclosure date was October 9, 2025.

The drug formulation is in tablet form, with the usage being a single oral dose of one tablet (specification: 100mg) of either the test or reference formulation per cycle for the subjects, taken with 240mL of water. The purpose of this trial is to evaluate the bioequivalence and safety of Sitagliptin Phosphate Tablets produced by Chengdu Hengrui Pharmaceutical Co., Ltd. compared to those manufactured by Hangzhou MSD Pharmaceutical Co., Ltd., under both fasting and fed conditions in healthy Chinese participants, providing evidence for the registration application of the test formulation.

Sitagliptin Phosphate Tablets are a chemical drug indicated for improving blood glucose control in patients with type 2 diabetes. Type 2 diabetes is a common metabolic disease caused by insulin resistance and insufficient secretion, with typical symptoms of "three more and one less," namely polydipsia, polyphagia, polyuria, and weight loss, which can be diagnosed through blood glucose testing.

The primary endpoint indicators of this trial include the peak plasma concentration (Cmax) and area under the drug concentration-time curve (AUC) of sitagliptin; secondary endpoint indicators include time to peak concentration (Tmax), elimination half-life (t1/2), etc., as well as vital signs monitoring, fingertip blood glucose monitoring, physical examination, clinical laboratory tests, electrocardiogram, clinical symptom observation and reporting, adverse events, and serious adverse events.

Currently, the experiment status is ongoing (not yet recruiting).

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Editor: Xiaolang Express