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An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interaction Between Tegoprazan and Novel Oral Anticoagulants (NOACs) After Multiple Oral Dosing in Healthy Volunteers

ClinicalTrials.gov · COMPLETED, 2023

87 participants

Abstract

This study aims to evaluate the effects of combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults.

Conditions: Healthy.

Primary outcome: AUCτ and Css,max of edoxaban; AUCτ and Css,max of apixaban; AUCτ and Css,max of rivaroxaban; AUECτ and Emax of Anti-Factor Xa activity, PT, aPTT, and Prothrombin (INR).

Enrollment: 87 participants.

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: 87 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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