Pharmacokinetic properties and bioequivalence of spironolactone tablets in fasting and fed healthy Chinese male subjects

Abstract

Based on pharmacokinetic parameters and the Chinese Food and Drug Administration's guidance and regulatory criteria for bioequivalence, the test and reference formulations of spironolactone were bioequivalent under both fasting and fed condition. Both formulations were generally well tolerated, with no adverse reaction reported.

High‐dose spironolactone lacks effectiveness in treatment of fibromyalgia (RCT)

“…Thus, bioequivalence of SPL formulations has to be tested for both SPL and canrenone. Indeed, bioequivalence of SPL drugs could be demonstrated for SPL (Xu et al., 2008) and canrenone (Li et al., 2016; Vergin et al., 1998). We used the original drug Aldactone ® .…”

Liquid chromatography-mass spectrometry for simultaneous determination of spironolactone and canrenone in plasma samples

“…Considering that the usual dose of SPI is 10 mg and has 90% bioavailability after oral administration (Li et al, 2016), for a 70 kg adult with a blood volume of 5 L, the method has to be able to unambiguously quantify more than 2 µg/mL of the drug in plasma in order to support pharmacokinetic studies. Based on the LOQ values shown in Table I (i.e., 0.20 and 0.08 µg/mL for SPI and CAN, respectively), the method can accurately quantify a 10-fold lower concentration of SPI and 25-fold lower concentration of CAN than what is required.…”