Evaluation of the comparative pharmacokinetic properties of a new orally disintegrating tablet of tegoprazan in healthy Korean subjects
Abstract
PURPOSE
Tegoprazan is a differentiated gastric acid-pump blocker and belongs to a class of potassium-competitive acid secretion blockers. An orally disintegrating tablet (ODT) of tegoprazan was developed to improve patient compliance. The purpose of this study was to compare pharmacokinetics (PK) and safety profiles between the conventional tablet (as the reference drug) and the ODT (as the test drug) of 50 mg tegoprazan in healthy Korean subjects.
MATERIALS AND METHODS
An open-label, randomized, single-dose, 6-sequence, 3-period crossover study was conducted in 48 healthy subjects. All subjects received a single oral dose of tegoprazan 50 mg tablet with water, tegoprazan 50 mg ODT with water, and tegoprazan 50 mg ODT without water. Serial blood samples were collected up to 48 hours after dosing. Plasma concentrations of tegoprazan and its metabolite M1 were measured by LC-MS/MS, and PK parameters were calculated with a non-compartmental method. Safety was evaluated by means of assessed adverse events, physical examinations, laboratory test results as well as measurements of vital signs and ECG throughout the study.
RESULTS
A total of 47 subjects completed the study. The 90% confidence intervals of the geometric mean ratios for AUCt, Cmax, and AUCinf of tegoprazan were 0.8873 - 0.9729, 0.8865 - 1.0569, and 0.8835 - 0.9695 for the test drug with water to the reference drug and 0.9169 - 1.0127, 0.9569 - 1.1276, and 0.9166 - 1.0131 for the test drug without water to the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 48 participants or records.
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