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Randomized Controlled Trial
. 2020 Dec;52(11-12):1640-1647.
doi: 10.1111/apt.16121. Epub 2020 Nov 1.

Pharmacodynamics of tegoprazan and revaprazan after single and multiple oral doses in healthy subjects

Jung Sunwoo  1 , Sang Chun Ji  1 , Jaeseong Oh  1 , Mu Seong Ban  1 , Ji Yeon Nam  2 , Bongtae Kim  2 , Geun Seog Song  2 , Kyung-Sang Yu  1 , In-Jin Jang  1 , SeungHwan Lee  1
Affiliations
Randomized Controlled Trial

Pharmacodynamics of tegoprazan and revaprazan after single and multiple oral doses in healthy subjects

Jung Sunwoo et al. Aliment Pharmacol Ther. 2020 Dec.

Abstract

Background: Potassium-competitive acid blockers (P-CABs) are emerging as novel treatments for acid-related disorders including gastroesophageal reflux disease. Tegoprazan and revaprazan are approved P-CABs in South Korea, but the pharmacodynamics and safety/tolerability of the two drugs have never been compared.

Aims: To evaluate the pharmacodynamics and safety/tolerability of tegoprazan and revaprazan after single and multiple oral doses METHODS: A randomised, open-label, active-controlled study was conducted in Helicobacter pylori-negative healthy Korean male subjects. Tegoprazan 50 mg or revaprazan 200 mg was administered orally, once daily for 7 days; 24-h intragastric pH monitoring and serum gastrin were measured for pharmacodynamic evaluation. Safety parameters including serum microRNA-122 (miR-122) level were also collected.

Results: After a single dose, the %Time pH ≥4 for tegoprazan was greater than that for revaprazan (54.5% vs 25.1%). After multiple doses, the %Time pH ≥4 for tegoprazan was also greater than that for revaprazan (68.2% vs 25.3%). %Time pH ≥4 during 12 hours at nighttime for tegoprazan was greater than that for revaprazan (71.8% vs 31.9%). The changes in the serum gastrin were not clinically significant for either drug. Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.

Conclusion: Tegoprazan 50 mg showed stronger gastric acid suppression than revaorazan 200 mg. Both drugs were well tolerated.

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References

REFERENCES

    1. Singendonk M, Goudswaard E, Langendam M, et al. Prevalence of gastroesophageal reflux disease symptoms in infants and children: a systematic review. J Pediatr Gastroenterol Nutr. 2019;68:811-817.
    1. Kahrilas PJ. GERD pathogenesis, pathophysiology, and clinical manifestations. Cleve Clinic J Med. 2003;70:S4-S19.
    1. Tutuian R, Castell DO. Nocturnal acid breakthrough-approach to management. MedGenMed. 2004;6:11.
    1. Heading RC. Proton pump inhibitor failure in gastro-oesophageal reflux disease: a perspective aided by the Gartner hype cycle. Clin Med. 2017;17:132-136.
    1. Furuta T, Shirai N, Sugimoto M, Nakamura A, Hishida A, Ishizaki T. Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies. Drug Metab Pharmacokinet. 2005;20:153-167.

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