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2002•The Chinese Journal of Clinical PharmacologyRequires access

Pharmacokinetics and Relative Bioavailability of Omeprazole Capsule in HealthyVolunteers after a Single Oral Administration

Qiu Fu

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Abstract

OBJECTIVE: To study the pharmacokinetics and relative bioavailabilityof omeprazole capsule in l8 healthy volunteers. METHODS: A single oral dose60mg omeprazole of reference or test drugs was given to each volunteer accordingto an open randomized crossover study. The concentrations in plasma weredetermined by RP-HPLC method. RESULT:The main pharmacokinetic parameters ofomeprazole were as follows:t(1/2)ke were (l.36±0.42)h and (l.26±0.45)h,tmax were(3.00±0.67)h and (2.83±0.57)h,Cmax were (l457.9±643.0)μg.L-1 and (l566.2±674.7)μg.L-1,AUC0-10 were(4740.2±266l.l)μg.h.L-1and (4963.9±2826.6)μg.h.L-1fortest and reference capsule respectively. The relative Bioavailability of AUC0-10 was96.73%±9.92%. CONCLUSION: The results of statistical analysis showed thattwo formulations were bioequivalent.

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OBJECTIVE: To study the pharmacokinetics and relative bioavailabilityof omeprazole capsule in l8 healthy volunteers. METHODS: A single oral dose60mg omeprazole of reference or test drugs was given to each volunteer accordingto an open randomized crossover study. The concentrations in plasma weredetermined by RP-HPLC method. RESULT:The main pharmacokinetic parameters ofomeprazole were as follows:t(1/2)ke were (l.36±0.42)h and (l.26±0.45)h,tmax were(3.00±0.67)h and (2.83±0.57)h,Cmax were (l457.9±643.0)μg.L-1 and (l566.2±674.7)μg.L-1,AUC0-10 were(4740.2±266l.l)μg.h.L-1and (4963.9±2826.6)μg.h.L-1fortest and reference capsule respectively. The relative Bioavailability of AUC0-10 was96.73%±9.92%. CONCLUSION: The results of statistical analysis showed thattwo formulations were bioequivalent.

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Available abstract

OBJECTIVE: To study the pharmacokinetics and relative bioavailabilityof omeprazole capsule in l8 healthy volunteers. METHODS: A single oral dose60mg omeprazole of reference or test drugs was given to each volunteer accordingto an open randomized crossover study. The concentrations in plasma weredetermined by RP-HPLC method. RESULT:The main pharmacokinetic parameters ofomeprazole were as follows:t(1/2)ke were (l.36±0.42)h and (l.26±0.45)h,tmax were(3.00±0.67)h and (2.83±0.57)h,Cmax were (l457.9±643.0)μg.L-1 and (l566.2±674.7)μg.L-1,AUC0-10 were(4740.2±266l.l)μg.h.L-1and (4963.9±2826.6)μg.h.L-1fortest and reference capsule respectively. The relative Bioavailability of AUC0-10 was96.73%±9.92%. CONCLUSION: The results of statistical analysis showed thattwo formulations were bioequivalent.

Key concepts: Bioequivalence, Omeprazole, Pharmacokinetics, Cmax, Bioavailability, Capsule, Crossover study, Volunteer

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