• YAKHAK HOEJI
• /
• v.39 no.4
• /
• pp.401-410
• /
• 1995

Pharmacolinetic profiles of omeprazole enteric coated granules including Ramezole$^\circledR$, Losec$^\circledR$, omeprazole-Na and omeprazole-resin salt were studied using the crossover design in rats and rabbits. The absorption variance of the preparations at the altered pH condition of the gastrointestinal tract was also studied. After oral administration of four omeprazole enteric coated pellets (10mg/kg) with and without concomitant administration NaHCO$_{3}$ (5 mg/ml, 60 mM) in the rats, the differences of absorplion rate and extent were evaluated. In the NaHCO$_{3}$, administration group, the T$_{max}$ appeared to be 2~10 times shorter than water administration group, and the $C_{max}$ also increased to about 4 times, and the AUC increased to about 2.5 times. Pharmacokinetic parameters of four omeprazole enteric coated pellets in rats showed no statistical significance (ANOVA, P>0.05) in both groups. In the crossover study, the second dosed drug showed 4~5 times increased bioavailability than first dosed drug, which shows the strong carry-over effect of acid secretion of the first dosed drug. The differences of the pharmacokinetic parameters of the two test formulations (Losec$^\circledR$ and omeprazole-resin) showed no statistical significance.

• Korean Journal of Clinical Pharmacy
• /
• v.10 no.2
• /
• pp.68-73
• /
• 2000

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.'