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KMID : 0369820080380050343
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 5 p.343 ~ p.348
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Bioequivalence of Cyclosporine A 100 mg Soft Capsules (Cipol-N(R)) vs. Sandimmun Neoral(R) in Healthy Korean Volunteers
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Huh Yong-Ho
Park Eun-A
Chung Youn-Bok
Pyo Hee-Soo
Kwon Oh-Seung
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Abstract
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The bioequivalence of two cyclosporine A (CyA) 100 mg soft capsules (Chong Kun Dang’s Cipol-N(R) as the test drug; Korea Novartis’ Sandimmun Neoral(R) as the reference drug) was assessed in healthy male Korean volunteers after oral administration of 200 mg CyA according to a randomized crossover design. The whole blood samples were analyzed for the determination of parent CyA in the blood by using a validated HPLC/diode array detector method. The mean AUCt values for reference and test products were 4095.3±1397.2 and 3958.3±1138.2 ng·hr/mL, respectively. The mean Cmax values were 1135.9±293.2 ng/mL for the reference product, and 985.5±207.9 ng/mL for the test product. Tmax was 1.6±0.4 hr for the reference and 1.8±0.5 hr for the test product. The differences of AUCt, Cmax and Tmax were -3.35, -13.28 and +10.63%, respectively. The point estimates and 90% confidence intervals for AUCt and Cmax were 0.981 (0.9171 to 1.0514) and 0.876 (0.8229 to 0.9336), respectively. Based on the pharmacokinetic and statistical data, we conclude that these two products are bioequivalent and can be considered interchangeable in the medical practice.
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KEYWORD
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Cyclosporine A, Bioequivalence, Pharmacokinetics, HPLC, Chong Kun Dang (Cipol-N(R)), Korea Novartis Sandimmun Neoral(R)
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