Effect of meal timing on pharmacokinetics and pharmacodynamics of tegoprazan in healthy male volunteers

• DOI: 10.1111/cts.12958
• Publication Date: 2020-12-31T22:38:32Z
• Authors: Deok Y. Yoon; Jung Sunwoo; Naree Shin; Ah R. Kim; Bongtae Kim; Geun S. Song; In‐Jin Jang; SeungHwan Lee
• Keywords: Pharmacodynamics; Crossover study

Tegoprazan, a novel potassium-competitive acid blocker, is used to treat acid-related diseases. However, there no information on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of marketed dosage tegoprazan under various meal timings in fed fasted state. The study aimed assess effect timing PKs PDs 50 mg after single administration healthy male subjects. An open-label, single-dose, three-treatment, three-period crossover was conducted. A total 12 subjects were orally administered dose among conditions: state, at 30 min before or high-fat meal. PK parameters estimated by noncompartmental method. Continuous 24-h intragastric pH monitoring done for PD analysis. compared timings. Compared with fasting condition, profile similar when meal; however, delayed absorption systemic exposure observed magnitude suppression evaluated through increased condition difference not clinically significant. Meal had significant mg. Therefore, could be regardless timing. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON TOPIC? QUESTION DID THIS STUDY ADDRESS? This food pharmacokinetics (PKs) pharmacodynamics (PDs) mealtime conditions. DOES ADD TO OUR KNOWLEDGE? showed that "after condition," amount condition" "fasting "before condition." In addition, gastric between whereas condition. HOW MIGHT CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? actual clinical environment, patients take medicine conditions, provided important about administering tegoprazan.