Pharmacokinetics and Pharmacodynamics during Treatment with the Omeprazole 20 mg Enteric-Coated Tablet and 20 mg Capsule in Asymptomatic Duodenal Ulcer Patients. (1st December 1997)

• Record Type: Journal Article
• Authors: Thomson, ABR; Kirdeikis, P; Lastiwka, R; Rohss, K; Sinclair, P; Olofsson, B
• Is Part Of: Canadian Journal of Gastroenterology. Volume 11:Number 8(1997)
• Page Start: 657
• Page End: 660
• Publication Date: 1997-12-01
• Subjects: Bioavailability -- Intragastric pH profile -- Omeprazole capsule -- Omeprazole enteric-coated tablet -- Repeated dosing conditions
• DOI: 10.1155/1997/910471
• Languages: English
• ISSNs: 0835-7900

Abstract

Abstract : This study compared the 24 h intragastric pH profile and bioavailability at repeated dosing conditions of the omeprazole 20 mg enteric-coated tablet versus the 20 mg capsule. Forty duodenal ulcer patients in asymptomatic remission completed this randomized open two-way crossover study. Omeprazole 20 mg tablets or capsules were administered for seven days in each period. A 24 h pH recording was performed before the start of treatment and on day 7 of each treatment period. Plasma concentrations of omeprazole were determined 24 h after the dose. The treatment periods were separated by two to four weeks. The difference in percentage of time with pH of at least 3 was less than 16% in favour of the tablet (not significant). The estimated mean area under the plasma concentration-time curve as well as the maximum plasma concentration (Cmax ) for omeprazole were 18% and 41% higher, respectively, for the tablet versus the capsule, with the latter percentage being statistically significant. The time to reach Cmax (tmax ) with the tablet was, on average, about 0.5 h longer than to reach the tmax of the capsule. This study indicates that the enteric-coated tablet formulation of omeprazole is biodynamically equivalent to the capsule regarding their effects on intragastric pH during repeated dosing.