Chengdu Hengrui Launches Bioequivalence Study for Metformin Hydrochloride and Glibenclamide Tablets (I) in Type 2 Diabetes Patients with Inadequate Glycemic Control

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Chengdu Hengrui Pharmaceutical Co., Ltd.'s Metformin and Glibenclamide Tablets (I) have initiated a single-dose, fasting/postprandial oral administration, randomized, open-label, two-formulation, two-period, crossover bioequivalence study in healthy subjects. The clinical trial registration number is CTR20254032, with the initial information disclosure date on October 20, 2025.

The drug is in tablet form. The administration method is as follows: Take 1 tablet on an empty stomach with 240mL of 20% glucose solution, and take another tablet after a meal with 240mL of warm water. It is administered as a single dose, with a 7-day dosing cycle, for a total of 2 cycles. The primary objective of this trial is to investigate the pharmacokinetic characteristics in Chinese healthy subjects after single-dose oral administration of the test formulation and reference formulation under fasting/postprandial conditions, and to evaluate the bioequivalence of the two formulations; the secondary objective is to assess the safety of single-dose oral administration of the test formulation and reference formulation in Chinese healthy subjects.

Metformin and Glibenclamide Tablets (I) are chemical drugs, indicated for patients with type 2 diabetes whose blood glucose levels are not satisfactorily controlled by metformin and glibenclamide therapy. Type 2 diabetes is a common chronic disease characterized by elevated blood glucose due to insufficient insulin secretion or defective insulin action, with symptoms including polydipsia, polyphagia, polyuria, weight loss, etc., and diagnosis relies on blood glucose testing.

The primary endpoint indicators of this trial include AUC0 - t, AUC0 - ∞, Cmax; secondary endpoint indicators include Tmax, λz, t1/2, AUC_%Extrap, F, CL/F, Vd/F; laboratory tests, physical examinations, vital signs, electrocardiograms; adverse events and serious adverse events.

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

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Editor: Xiaolang Express