Evaluating the bioequivalence and safety of liraglutide injection versus Victoza^® in healthy Chinese subjects: a randomized, open, two-cycle, self-crossover phase I clinical trial.

ABSTRACT: Background: Liraglutide is an acylated glucagon-like peptide-1 (GLP-1) analog, and its pharmacokinetic and pharmacodynamic properties as a GLP-1 receptor (GLP-1R) agonist make it an important therapeutic option for many patients with type 2 diabetes mellitus. This study compared the bioequivalence and safety of liraglutide with the originator product in healthy Chinese adult subjects. Methods: Subjects (N = 36, both sexes) were randomized in a 1:1 ratio into two groups (18 cases each) for a two-cycle, self-crossover trial. Each cycle involved a single subcutaneous injection of the test and reference drugs, with a washout period of 14 days. The plasma drug concentration was quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The main pharmacokinetic parame

SUBMITTER: Liu C 

PROVIDER: S-EPMC10766854 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature