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Equipotent inhibition of gastric acid secretion by equal doses of oral or intravenous pantoprazole
Author(s) -
M. Hartmann,
Anne Ehrlich,
H. Fuder,
R Lühmann,
S. Emeklibas,
Wolfgang Timmer,
W. Wurst,
P. W. Lücker
Publication year - 1998
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1998.00406.x
Subject(s) - pantoprazole , medicine , crossover study , proton pump inhibitor , pharmacokinetics , oral administration , regimen , gastroenterology , gastric acid , confidence interval , stomach , pharmacology , anesthesia , omeprazole , placebo , alternative medicine , pathology
Background: Pantoprazole is a proton pump inhibitor characterized by a low potential to interact with the cytochrome P450 system, and linear pharmacokinetics. The recommended oral dose for treatment of acid‐related diseases is 40 mg. Methods: Using a randomized, crossover study design we compared the ability of 40 mg oral and intravenous pantoprazole to elevate the intragastric pH in healthy volunteers ( n = 20, ‘per protocol’), during two treatment phases. The duration of each phase was 5 days. Pantoprazole 40 mg was administered once daily either as a tablet or as an intravenous injection. A 24 h pH‐metry was used to record the intragastric pH on day 5 of each regimen; this was compared to the baseline curve obtained before each study period. The calculated 90% confidence intervals (90% CI) represent the mean difference in the intragastric pH, attained after intravenous or oral administration. The predefined equivalence range for the 90% CI was ± 20% for the percentage time at which the gastric pH was at least pH 3 or 4 and ± 1 unit for the median pH. Results: Pantoprazole was well tolerated during both treatment phases. The mean of the 24 h median pH was 3.3 and 3.1 for the intravenous and oral treatments, respectively; the corresponding differences were 0.2 (90% CI: – 0.03 to 0.44). For the mean percentage time at which the pH was 3 or above, the respective calculated values were 57% and 51%, with a difference between the two administration routes of only 5.7% (90% CI: 1.8 to 9.6). At an intragastric pH of 4 or above, the mean percentage time was 42% and 38% following intravenous and oral treatment, respectively, with a difference between the treatment routes of only 4.4% (90% CI: 0.6 to 8.3). Conclusions: These results imply that the two formulations of pantoprazole can be assumed to be equipotent. Hence, the intravenous formulation of pantoprazole could be considered as an alternative route of administration.