A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals

C. Cheng
M.-L. Chen
C. Tseng
Y.-S. Uang
C.-L. Huang
K.-Y. Hsu

Abstract

The purpose of this study is to evaluate the only available calcium p-aminosalicylate (Ca PAS) commercial product, which is one of the most commonly prescribed non-surveillance products fromthe Bureau of National Health Insurance (BNHI) database in Taiwan. An openrandomized, balanced, two-way crossover study was designed to evaluate the relative bioavailability (F) of a 500 mg Ca PAS F.C. tablet with a 500 mg Ca PAS suspension in 13 healthy individuals. Blood samples were collected according to a planned time schedule. The plasma concentrations of PAS were measured by a validated liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) method. Pharmacokinetic parameters of area under the plasma concentration-time curve from the time zero to the time of last quantifiable concentration (AUC0-t), area under the plasma concentration-time curve from time zero to infinity (AUC0eN), maximum plasma concentration (Cmax), time to reach measured maximum plasma concentration (Tmax), elimination half-life (T1/2), and mean residence time (MRT) were determined by non-compartment methods. F was calculated by [AUC0-N] of the test drug divided by [AUC0-N] of the reference drug. The mean geometric ratios of pharmacokinetic parameters, including AUC0-t, AUC0eN, and Cmax obtained were 0.873, 0.874, and 0.569, respectively. The 90% confidence intervals of ln (AUC0-t), ln (AUC0-N), and ln (Cmax) after being back natural log-transformed were (74.0e103.0%), (74.1e103.0%), and (38.4e84.3%), respectively. The relative bioavailability of the Ca PAS tablet was 87.4%. Copyright © 2013, Food and Drug Administration, Taiwan.

ScienceDirect Link

10.1016/j.jfda.2013.09.014

Recommended Citation

Cheng, C.; Chen, M.-L.; Tseng, C.; Uang, Y.-S.; Huang, C.-L.; and Hsu, K.-Y. (2014) "A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals," Journal of Food and Drug Analysis: Vol. 22 : Iss. 2 , Article 5.
Available at: https://doi.org/10.1016/j.jfda.2013.09.014