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

Chinhwa Cheng, Mei Ling Chen, Chiachi Tseng, Yow Shieng Uang, Chyn Liang Huang, Kuang Yang Hsu

Research output: Contribution to journalArticle

5 Citations (Scopus)

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%.

Original languageEnglish
Pages (from-to)242-247
Number of pages6
JournalJournal of Food and Drug Analysis
Volume22
Issue number2
DOIs
Publication statusPublished - Jun 1 2014

Fingerprint

films (materials)
Biological Availability
Tablets
coatings
bioavailability
Calcium
calcium
pharmacokinetics
health insurance
drugs
liquid chromatography
half life
Taiwan
confidence interval
Pharmacokinetics
blood
National Health Programs
Tandem Mass Spectrometry
methodology
Liquid Chromatography

Keywords

  • Calcium p-aminosalicylate (Ca PAS)
  • Relative bioavailability (F)

ASJC Scopus subject areas

  • Food Science
  • Pharmacology

Cite this

A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals. / Cheng, Chinhwa; Chen, Mei Ling; Tseng, Chiachi; Uang, Yow Shieng; Huang, Chyn Liang; Hsu, Kuang Yang.

In: Journal of Food and Drug Analysis, Vol. 22, No. 2, 01.06.2014, p. 242-247.

Research output: Contribution to journalArticle

Cheng, Chinhwa ; Chen, Mei Ling ; Tseng, Chiachi ; Uang, Yow Shieng ; Huang, Chyn Liang ; Hsu, Kuang Yang. / A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals. In: Journal of Food and Drug Analysis. 2014 ; Vol. 22, No. 2. pp. 242-247.
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