e-journal

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

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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 (AUC0et), 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 [AUC0eN] of the test drug divided by [AUC0eN] of the reference drug. The mean geometric ratios of pharmacokinetic parameters, including AUC0et, AUC0eN, and Cmax obtained were 0.873, 0.874, and 0.569, respectively. The 90% confidence intervals of ln (AUC0et), ln (AUC0eN), 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%.

Keywords:
Calcium p-aminosalicylate (Ca PAS) Relative bioavailability (F)

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Informasi Detail

Judul Seri

j o u rnal of food and drug a n a l y s i s

No. Panggil

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Penerbit

: Elsevier Taiwan., 2014

Deskripsi Fisik

j o u rnal of food and drug a n a l y s i s 2 2 ( 2 0 1 4 ) 2 4 2 e2 4 7

Bahasa

English

ISBN/ISSN

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Klasifikasi

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Tipe Isi

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Tipe Media

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Tipe Pembawa

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Edisi

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Subjek

Food And Health

Info Detail Spesifik

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Pernyataan Tanggungjawab

Wati/Agus

Versi lain/terkait

Lampiran Berkas

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