NCT03378284

A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

A Randomized, Open-label, Active-controlled, Multiple Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, and Pharmacodynamics of Tegoprazan After Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Detailed description

* To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers. * To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Conditions

• Pharmacodynamics
• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Tegoprazan	Tegoprazan QD for 7 days
DRUG	Revaprazan	Revaprazan QD for 7 days

Timeline

• Start date: 2017-12-10
• Primary completion: 2017-12-23
• Completion: 2018-01-16
• First posted: 2017-12-19
• Last updated: 2018-03-30

Locations

1 site across 1 country: South Korea