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KMID : 0369819930230010041
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Jorunal of Korean Pharmaceutical Sciences
1993 Volume.23 No. 1 p.41 ~ p.49
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Bioequivalence of Enteric - coated Omeprazole Products
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김종국/Kim CK
정은주/이은진/신희종/이원근/Jeong EJ/Lee EJ/Shin HJ/Lee WK
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Abstract
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The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was Rosec® capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2×2 Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) (AUC0?8hr) (1946.5±675.3vs2018.3±761.6ng?hr/ml), AUC from time zero to infinite (AUCo?∞) (2288.6±1212.8vs2264.9±1001.3ng?hr/ml), maximum plasma concentration (Cmax) (772.5±283.3vs925.8±187.7ng/ml), time to maximum plasma concentration (Tmax) (2.38±1.06vs2.34±1.09hr), apparent elimination rate constant (kℓ) (0.5339±0.2687vs0.5769±0.2184hr?I), apparent absorption rate constant (ka) (1.1536±0.5278vs0.9739±0.9507hr?1) and mean residence time (MRT) (3.13±0.73vs3.41±1.04hr). The differences of mean (AUC0?8hr), Cmax, Tmax and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power (1?β) and treatment difference (△) for AUCo?8hr Cmax and MRT were more than 0.8 and less than 0.2, respectively. Although the power for Tmax was under 0.8, Tmax of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of Rosec® capsule. Therefore, two products are bioequivalent based on the current results.
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KEYWORD
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Bioequivalence, Bioavailability, Omeprazole, Oral absorption, Pharmacokinetics, Enteric coated product
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