Authors:

Yu Kyong Kim

Department of Clinical Pharmacology and Therapeutics, Chungbuk National University College of Medicine and Hospital, Republic of Korea.

Abstract:

Proton-pump inhibitors, including rabeprazole, are susceptible to stomach acid breakdown. The use of entericcoated (EC) formulations reduces this issue, although their slower onset time is a drawback. A Fixed-Dose Combination (FDC) tablet containing rabeprazole and sodium bicarbonate, which was utilised to elevate the intragastric pH, was compared to a traditional extended-release (EC) tablet. Materials and procedures To assess PK and PD features, a 40-subject, randomised, open-label, multiple-dose, 2-treatment, 2-sequence, 2-period crossover research was conducted. During each period, eligible subjects were given either 20 mg rabeprazole EC tablets for 7 days or 20 mg rabeprazole plus 800 mg sodium bicarbonate FDC tablets. On days 1 and 7, serial blood samples were taken for up to 24 hours.The PK parameters for rabeprazole were calculated using non compartmental techniques. On days -1, 1 and 7, ambulatory pH monitoring was done to figure out the PD parameters. The criteria that the FDC-to-EC tablet ratio fell within the range of 0.80-1.25 allowed for a quantitative comparison based on the 90% Confidence Interval (90% CI) of the area under the concentration vs. time curve over the dosing interval (AUCtau,ss) and the percentage decrease from baseline in Integrated Gastric Acidity (% IGA) after 24 hours.

Citation:

Yu Kyong Kim. Pharmacokinetic and Pharmacodynamic Evaluation of a Sodium Bicarbonate Combination of Rabeprazole, a Proton-Pump Inhibitor, in HealthySubjects. Clinical Imaging and Case Reports 2023.