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KMID : 0941820000100020068
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Korean Journal of Clinical Pharmacy
2000 Volume.10 No. 2 p.68 ~ p.73
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Bioequivalence Evaluation of Omeprazole Preparations
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Abstract
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The bioequivalence of two omeprazole preparations was evaluated following their oral administration to 16 normal volunteers. The test product was ’’Ulpro tablet’’ made by Boryung Pharmaceutical Co. and the reference was ’’Losec capsule’’ made by Yuhan Corp. After one capsule or tablet containing 20 mg omeprazole was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method. AUC and C_{max} were determined and analyzed statistically for the evaluation of bioequivalence of the two products. The differences in AUC and C_max between two products were 0.45%;and;2.83%, respectively. The powers for AUC and C_{max};were;89.2%;and;>90%, respectively. Confidence intervals were within 20% for AVC and C_{max}All of these parameters met the criteria of KFDA for bioequivalence, indicating that ’’Ulpro tablet’’ is bioequivalent to ’’Losee capsule.’’
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