PI-049 - COMPARISON OF THE ACID SUPPRESSION EFFECTS BETWEEN LOW-DOSE ESOMEPRAZOLE AND FAMOTIDINE IN HEALTHY SUBJECTS.

H. Kim¹, J. Hwang¹, J. Kim¹, C. Seong¹, J. Lee¹, B. Kim¹, H. Kim², H. Kim², Y. Kim¹, M. Park¹; ¹Chungbuk National University Hospital, Cheong-ju, Republic of Korea, ²Daewon Pharmaceutical Co., Ltd., Seoul, Republic of Korea.

Background: Famotidine, an H2 receptor antagonist (H2RA), is mainly prescribed to alleviate the early symptoms of gastritis. However, H2RA has some limitations such as dosage for patients with renal impairment, so there is a demand for the use of other gastric acid inhibitors in the treatment of gastritis. In this study, the pharmacodynamic (PD) characteristics of esomeprazole, a proton pump inhibitor, were compared with famotidine.

Methods: A randomized, multiple-dose, 6x3 crossover study was conducted with a 7-day washout between the periods. For each period, the subjects were administered DW1903 (esomeprazole 10 mg), DW1903-R1 (famotidine 20 mg), or DW1903-R2 (esomeprazole 20 mg) once daily for 5 days. To confirm the PD characteristics of famotidine and esomeprazole, the 24-h gastric pH was recorded after a single and multiple dose. The mean percentage of time for which gastric pH was above 4 was evaluated for PD assessment. Information regarding adverse events (AEs), concomitant medication, clinical laboratory test findings, vital sign values, and physical examination and electrocardiogram results were assessed for safety evaluation.

Results: Twenty-six subjects completed the study. Following multiple doses of DW1903, DW1903-R1, and DW1903-R2, the mean percentages of time during which gastric pH was above 4 over 24 h were 35.77 ± 19.56%, 24.48 ± 17.36%, and 53.75 ± 20.55%, respectively. All AEs were mild in severity, and other safety parameters had no clinically significant change.

Conclusion: After multiple doses of esomeprazole and famotidine, the percentage of time for which gastric pH was above 4 in the DW1903 group was comparable to that of DW1903-R1. Both drugs were found to be safe and tolerable after multiple doses. These findings give support for further evaluation of DW1903 as a treatment option for gastritis.