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Effect of meal timing on pharmacokinetics and pharmacodynamics of tegoprazan in healthy male volunteers
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  • Deok Yong Yoon,
  • Jung Sunwoo,
  • Naree Shin,
  • Ah Rong Kim,
  • Bong Tae Kim,
  • Geun Seog Song,
  • In-Jin Jang,
  • SeungHwan Lee
Deok Yong Yoon
Seoul National University College of Medicine and Hospital
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Jung Sunwoo
Asan Medical Center, University of Ulsan College of Medicine
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Naree Shin
HK inno.N Corporation
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Ah Rong Kim
HK inno.N Corporation
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Bong Tae Kim
HK inno.N Corporation
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Geun Seog Song
HK inno.N Corporation
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In-Jin Jang
Seoul National University College of Medicine and Hospital
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SeungHwan Lee
Seoul National University College of Medicine and Hospital
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Abstract

Tegoprazan, a novel potassium-competitive acid blocker, is used to treat acid-related diseases. However, there is no information on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the marketed dosage of tegoprazan under various meal timings in a fed and fasted state. The study aimed to assess the effect of meal timing on PKs and PDs of tegoprazan 50 mg after a single administration in healthy male subjects. An open-label, single-dose, three-treatment, three-period crossover study was conducted. A total of 12 subjects were orally administered a single dose of tegoprazan 50 mg among various conditions: in a fasted state, at 30 min before or 30 min after a high-fat meal. PK parameters were estimated by non-compartmental method. Continuous 24-hour intragastric pH monitoring was done for PD analysis. The PKs and PDs of tegoprazan were compared among the various meal timings. Compared to the fasting condition, the PK profile of tegoprazan was similar when administered 30 min before a high-fat meal; however, delayed absorption with similar systemic exposure was observed when administered 30 min after a high-fat meal. The magnitude of acid suppression evaluated through the PD parameters increased when administered 30 min after a high-fat meal compared to fasting the condition and when administered 30 min before a high-fat meal. However, the increased difference in acid suppression was not clinically significant. Meal timing had no clinically significant effect on the PKs and PDs of tegoprazan 50 mg. Therefore, the marketed dosage of tegoprazan could be administered regardless of the meal timing.

Peer review status:POSTED

10 Sep 2020Submitted to British Journal of Clinical Pharmacology
10 Sep 2020Assigned to Editor
10 Sep 2020Submission Checks Completed