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

• DOI: 10.3389/fphar.2023.1326865
• Publication Date: 2023-12-22T04:43:32Z
• Authors: Chao Liu; Hongrong Xu; Fei Yuan; Hanjing Chen; Lei Sheng; Weili Chen; Haisong Xie; Hongmei Xu; Xuening Li
• Keywords: Bioequivalence; Crossover study; Pharmacodynamics

Background: Liraglutide is an acylated glucagon-like peptide-1 (GLP-1) analog, and its pharmacokinetic pharmacodynamic properties as a GLP-1 receptor (GLP-1R) agonist make it important therapeutic option for many patients with type 2 diabetes mellitus. This study compared the bioequivalence safety of liraglutide originator product in healthy Chinese adult subjects. Methods: Subjects (N = 36, both sexes) were randomized 1:1 ratio into two groups (18 cases each) two-cycle, self-crossover trial. Each cycle involved single subcutaneous injection test reference drugs, washout period 14 days. The plasma drug concentration was quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS). main parameters statistically analyzed to assess bioequivalence. Furthermore, drugs assessed throughout Results: geometric mean ratios C max , AUC 0-t 0-∞ 103.73%, 103.01%, 103.03%, respectively, their 90% confidence intervals (CIs) consistent range 80.00%–125.00%, indicating that formulations had similar pharmacokinetics. Meanwhile, results showed well tolerated. Conclusion: Studies have shown has drug. Clinical trial registration: ( http://www.chinadrugtrials.org.cn/index.html ), identifier (CTR20171303).