Related Experiment Video
Updated: Mar 20, 2026

Network Pharmacology Prediction and Metabolomics Validation of the Mechanism of Fructus Phyllanthi against Hyperlipidemia
Published on: April 7, 2023
Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects
Yi Zhang1,2, Meixia Hua2, Lijie Du1,2
1School of Pharmacy, Hubei University of Science and Technology, Xianning, 437100, Hubei, China.
Background And Objective:
This study evaluated the pharmacokinetic characteristics, bioequivalence, and safety of propafenone hydrochloride tablets under fasting conditions in healthy Chinese subjects.
Methods:
This was a single-center, randomized, open-label, two-formulation, single-dose study using a four-period fully replicated crossover design. A total of 36 subjects were randomized 1:1 to two sequence groups and received the test (T) or reference (R) formulation in each period. Plasma concentrations of propafenone and its active metabolite, 5-hydroxypropafenone, were quantified using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters were derived by noncompartmental analysis using Phoenix WinNonlin 7.0. Bioequivalence was assessed using reference-scaled average bioequivalence (RSABE) based on the within-subject standard deviation (SWR) of the reference product for area under the concentration-time curve from time 0 to the last time (AUC0-t), area under the concentration-time curve from time 0 to infinity (AUC0-∞), and maximum plasma drug concentration (Cmax).
Results:
Overall, 35 subjects completed the study. After administration of T and R, mean (± standard deviation [SD]) propafenone Cmax, AUC0-t, and AUC0-∞ were 52.81±70.44 versus 50.11±60.96 ng/mL, 174.98±220.13 versus 165.25±204.39 h/ng/mL, and 184.19±222.71 versus 171.31±206.53 h/ng/mL, respectively. For 5-hydroxypropafenone, Cmax, AUC0-t, and AUC0-∞ were 68.95±42.09 versus 66.55±33.52 ng/mL, 234.08±150.88 versus 223.33±141.50 h/ng/mL, and 241.43±151.53 versus 230.11±142.83 h/ng/mL, respectively. RSABE analysis indicated that the geometric mean ratios (T/R) for propafenone Cmax, AUC0-t, and AUC0-∞ were 101.04%, 106.27%, and 105.32%, all within the acceptance range of 80.00-125.00%.
Conclusions:
Under fasting single-dose conditions, the test and reference propafenone hydrochloride tablets met bioequivalence criteria in healthy Chinese subjects.
More Related Videos
08:59An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
09:24Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Related Concept Videos
Bioavailability Study Design: Healthy Subjects Versus Patients
Modified-Release Drug Delivery Systems: Bioavailability
Bioequivalence: Overview
Bioequivalence of Drugs: Drugs with Multiple Indications
Measurement of Bioavailability: Pharmacodynamic Methods
Dosage Regimens: Partial Pharmacokinetic Parameters