Pharmacokinetics and pharmacodynamics during treatment with the omeprazole 20 mg enteric-coated tablet and 20 mg capsule in asymptomatic duodenal ulcer patients

Can J Gastroenterol. 1997 Nov-Dec;11(8):657-60. doi: 10.1155/1997/910471.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anti-Ulcer Agents / administration & dosage*
  • Anti-Ulcer Agents / blood
  • Anti-Ulcer Agents / pharmacokinetics
  • Anti-Ulcer Agents / pharmacology
  • Area Under Curve
  • Biological Availability
  • Capsules
  • Chemistry, Pharmaceutical
  • Cross-Over Studies
  • Duodenal Ulcer / drug therapy*
  • Female
  • Gastric Acid / metabolism
  • Humans
  • Hydrogen-Ion Concentration
  • Linear Models
  • Male
  • Microelectrodes
  • Middle Aged
  • Omeprazole / administration & dosage*
  • Omeprazole / blood
  • Omeprazole / pharmacokinetics
  • Omeprazole / pharmacology
  • Tablets, Enteric-Coated
  • Therapeutic Equivalency
  • Time Factors

Substances

  • Anti-Ulcer Agents
  • Capsules
  • Tablets, Enteric-Coated
  • Omeprazole