A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

Phase 1 Completed 30 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose of DBPR108 tablets in Type 2 Diabetes Mellitus Patients.

Timeline

Start: 2021-12-30
Primary completion: 2022-03-28
Completion: 2022-03-28

Publications

Liu W, Yang K, Lin Y, Lu C, Liu J, Zhou H, Wang J, Zhang T, Yao L, Qi H, Zhang X, Jia R, Li X, Jing S. Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes. Clin Pharmacokinet. 2025 May;64(5):703-713. doi: 10.1007/s40262-025-01501-8. Epub 2025 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DBPR108	Small molecule	50 mg	Oral
Subject	DBPR108	Small molecule	100 mg	Oral
Subject	DBPR108	Small molecule	200 mg	Oral

A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

Summary

Timeline

Publications

Drugs

Indications