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) oi pantoprazole influences the effect of a 40 mg dose upon intragastric pH in healthy subjects. Design: 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. Conclusion: The study supports the recommendation of a once-daily morning dosage regimen of pantoprazole 40 mg in the treatment of acid-related diseases.