NCT05723510

PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 54 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A randomized, open-label, multiple-dose, two-arm, two-period crossover study \[Cohort 1\] To evaluate the effects of combination therapy of tegoprazan and edoxaban on the pharmacokinetic and pharmacodynamic properties of edoxaban in healthy adults. \[Cohort 2\] To evaluate the effects of combination therapy of tegoprazan and apixaban on the pharmacokinetic and pharmacodynamic properties of apixaban in healthy adults. \[Cohort 3\] To evaluate the effects of combination therapy of tegoprazan and rivaroxaban on the pharmacokinetic and pharmacodynamic properties of rivaroxaban in healthy adults.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tegoprazan 50mg	Oral administration of one tablet of tegoprazan 50 mg once daily
DRUG	Edoxaban 60mg	Oral administration of one tablet of edoxaban 60 mg once daily
DRUG	Apixaban 5mg	Oral administration of one tablet of apixaban 5 mg twice daily
DRUG	Rivaroxaban 20mg	Oral administration of one tablet of rivaroxaban 20 mg once daily

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-07-17
• Completion: 2023-07-24
• First posted: 2023-02-10
• Last updated: 2023-12-11

Locations

1 site across 1 country: South Korea