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A Bioavailability Study of Indonesian Generic Tablet of Captopril In Heathy Volunteers

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Captopril is a selective- Inhibitor of angiotensin-convertinq enzyme (ACE) and is formulaned by, several pharmaceuical companies: irr Lndonesia. This stwdy was corrducted to compare tlhe bioavailability of captopril' tablet with reference preducts in healthy volunteers. The relative bioavailability of captopril was deterrnined in single dase, randomized, crcssover, and two-phase studies. The relative: bioavailability of the test product (a generic captapril 50 mg tablet), with respect to the reference peoduct was deterrninedi. Twelve. healthy volunteers. in two groups took part in these studies and took either the test or reference tablets in the first phase and received the other tablet in the second phase of each study; The bioavailability parameters include the peak concentration of captopril in serum (Cmax); the time to achieve the peak concentratiorr (Tmax); and the area under the curve of captopril in serurn versus time, Non-compartmental analysis on observed concentratiorr versus time data has resulted in the mean value of Cmax of 545.26± 22.90. ng/rnl, (test product) and 548.91 ± 25.0.7 ng/mL (reference product) and mean Tmax of 1.3 ± 0.08 hours (tes product) and 1.08 + 0.08 hours (reference product), mean of AUCo-7 value of 1820.51 ± 75.31 ng hour/mL (tesn product) and 1822.09 ± 99.29 ng hour/mL (reference product), and mean of AUCo-inf value of 1967l ± 95.65 ng. Hour/mL (test product) and 1996.94 ±.124.52 ng hour/mL (reference product). Based on the data, it can be concluded that there is no significant dlffeernce. (p>0.05) in biovailability between both captopril tablet (test and reference product).
Keywords: Bioequivalence, Captopril HPLC, Human serum; Generic

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Ketersediaan

Informasi Detail

Judul Seri

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No. Panggil

Indonesian Journal of Pharmacy, 23 (3) 2012 : 183-

Penerbit

Yogyakarta : Faculty of Pharmacy Universitas Gajah Mada Yogyakarta., 2012

Deskripsi Fisik

5p

Bahasa

ISBN/ISSN

0126-1037

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

CAPTOPRIL

Info Detail Spesifik

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Pernyataan Tanggungjawab

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Versi lain/terkait

Lampiran Berkas

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