Morning and evening administration of pantoprazole: a study to compare the effect on 24-hour intragastric pH.
OBJECTIVE
To determine whether the time of administration (morning vs. evening) of pantoprazole influences the effect of a 40 mg dose upon intragastric pH in healthy subjects.


METHODS
Randomized, double-blind, two-period crossover study to compare intragastric pH following treatment with pantoprazole, 40 mg once daily for 7 days, the drug being given as either a morning or an evening dose before meals.


METHODS
Intragastric pH was measured for 24 h on three occasions. The baseline recording was made 2 days prior to the first treatment period and subsequent measurements were made on days 6 to 7 of each period. Adverse events were recorded and fasting laboratory variables measured.


RESULTS
Twelve subjects were evaluable for efficacy. Increases in median pH over 24 h were observed in all subjects with both dosage regimens. There was a greater increase from baseline in 24-h median pH values following morning than evening administration of pantoprazole (P < 0.05). This difference was due to a greater effect on median daytime pH (07.00-19.00 h, P < 0.01) compared with that after evening administration. No adverse events were reported and there were no clinically significant changes in laboratory variables.


CONCLUSIONS
The study supports the recommendation of a once-daily morning dosage regimen of pantoprazole 40 mg in the treatment of acid-related diseases.
Müssig
S
S
Witzel
L
L
Lühmann
R
R
Schneider
A
A
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000328:Adult; D001562:Benzimidazoles / Q000008:administration & dosage*; D002940:Circadian Rhythm / Q000502:physiology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D005260:Female; D005744:Gastric Acid / Q000502:physiology; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D012016:Reference Values; D013454:Sulfoxides / Q000008:administration & dosage*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D004791:Enzyme Inhibitors; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole