Investigation of the bioequivalence of two lansoprazole formulations in healthy Chinese volunteers after a single oral administration
Abstract
The objective of this study was to compare two lansoprazole products (the reference brand enteric-coated capsules and the test generic enteric-coated tablets), and the key pharmacokinetic (PK) parameters for both formulations and their metabolites were assessed. The study used an open-label, randomized two-period crossover design with an 8-day washout period between doses in 24 healthy subjects under fasting conditions. The concentration of lansoprazole and its two metabolites was determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The in vitro release of lansoprazole from the test and reference formulations was within the acceptable limits. The relationship between concentration and peak area ratio was found to be linear within the range for lansoprazole and metabolites. The point estimates (ratios of geometric mean) of lansoprazole and two main metabolites were between 94.3% and 105.1% for AUC0-t, AUC0-∞, and Cmax. No statistically significant difference between the two formulations was found. The results of in vitro and in vivo suggested equivalent clinical efficacy of the two brands.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 24 participants or records.
Read the paper
Related studies
- The Prediction of the In Vitro Release Curves for PLGA-Based Drug Delivery Systems with Neural Networks
- Promising Ursolic Acid as a Novel Antituberculosis Agent: Current Progress and Challenges
- Proof of principle concept for the analysis and functional prediction of rare genetic variants in the CYP2C19 and CYP2D6 genes
- Fabrication, characterization, and docking studies of furosemide-loaded nanosponges using the emulsion solvent diffusion method
- The Effect of Concomitant Administration of Proton Pump Inhibitors on the Pharmacokinetics of CDK4/6 Inhibitors in Rats: Implications for the Evaluation of Hepatic and Transporter-Mediated Drug–Drug Interactions
- Mining the Metabolic Capacity of Clostridium sporogenes Aided by Machine Learning
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.