Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial.
Expert Rev Clin Pharmacol
; 16(4): 363-370, 2023 Apr.
Article
em En
| MEDLINE
| ID: mdl-36883362
ABSTRACT
BACKGROUND:
Glucagon-like peptide-1 (GLP-1) is an endogenous incretin hormone. Liraglutide, a GLP-1 receptor agonist, can lower blood sugar by increasing insulin production and inhibiting the production of glucagon. This study researched the bioequivalence and safety of the test and reference drugs in healthy Chinese subjects. RESEARCH DESIGN ANDMETHODS:
Subjects (N = 28) were randomly divided into group A and group B at a ratio of 11 for a two-cycle cross-over study. There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively. The washout was set at 14 days. Plasma drug concentrations were detected by specific liquid chromatography and tandem mass spectrometry (LC-MS/MS) assays. Statistical analysis of major pharmacokinetic (PK) parameters was conducted to assess drug bioequivalence. In addition, we evaluated the safety of the drugs throughout the trial.RESULTS:
The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for the test and reference drugs were 107.11%, 106.56%, 106.09%, respectively. The 90% confidence intervals (CIs) were all within 80%-125%, meeting the bioequivalence standards. In addition, both had good safety in this study.CONCLUSION:
The study shows that the two drugs had similar bioequivalence and safety. CLINICAL TRIAL REGISTRATION DCTR CTR20190914; ClinicalTrials.gov NCT05029076.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Liraglutida
/
População do Leste Asiático
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
Expert Rev Clin Pharmacol
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
China