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Study of the pharmacokinetics and intragastric pH of rabeprazole given as successive intravenous infusion to healthy Chinese volunteers.
- Source :
- European Journal of Clinical Pharmacology; Jan2011, Vol. 67 Issue 1, p25-31, 7p, 2 Charts, 3 Graphs
- Publication Year :
- 2011
-
Abstract
- Objectives: To investigate the pharmacokinetics and pharmacodynamics of rabeprazole (RPZ) given as successive intravenous infusion to healthy Chinese volunteers. Methods: A total of 63 subjects (33 males and 30 females) were recruited at four research centers and given a 5-day therapeutic course of RPZ (10, 20, or 40 mg) administered as single daily doses during a 30-min period. Plasma concentrations were monitored by sampling at very short intervals for the first 330, 360, or 420 min post-RPZ administration. Intragastric pH was recorded 24 h post-RPZ administration on day 1 and day 5. Results: After receiving a single and repeated doses of RPZ, the area under the plasma concentration-time curve (AUC) was 51.9 ± 22.1, 96.7 ± 27.6, and 188.4 ± 65.8 mg·min/L on day 1 and 59.3 ± 23.9, 106.7 ± 27.8, and 200.3 ± 79.0 mg·min/L on day 5 for the low-, middle-, and high-dose groups, respectively. The corresponding peak concentrations (C) were 0.64 ± 0.11, 1.30 ± 0.26, and 2.6 ± 0.54 μg/mL on day 1 and 0.76 ± 0.15, 1.39 ± 0.25, and 2.91 ± 0.53 μg/mL on day 5, respectively. Although the mean AUC and C values increased from a single dose to repeated doses in the three groups, the difference was not significant. The mean AUC and C ratios of repeated dose to single dose were 1.14, 1.10, and 1.06 on day 1 and 1.19, 1.07, and 1.12 on day 5 for the low-, middle-, and high-dose groups, respectively. After administration of a single dose, the 24-h pH value was significantly higher in the high-dose group than in the low-dose group. After repeated doses, significant increases in pH were observed in the low-, middle-, and high-dose groups; however, the between-group differences were not statistically significant. Conclusions: There is a relationship between the pharmacokinetics and pharmacodynamics of RPZ, with the latter depending in part on the duration of administration, as evidenced by a higher AUC or C and intragastric pH from repeated dosing. [ABSTRACT FROM AUTHOR]
- Subjects :
- ACADEMIC medical centers
BODY fluid analysis
ANALYSIS of variance
GASTRIC acid
GENETIC polymorphisms
HYDROGEN-ion concentration
INFUSION therapy
INTRAVENOUS therapy
OXIDOREDUCTASES
RESEARCH funding
STATISTICAL hypothesis testing
T-test (Statistics)
PROTON pump inhibitors
DRUG dosage
PHARMACODYNAMICS
Subjects
Details
- Language :
- English
- ISSN :
- 00316970
- Volume :
- 67
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- European Journal of Clinical Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 56792757
- Full Text :
- https://doi.org/10.1007/s00228-010-0949-4