NCT03530228

A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males. * To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males. * To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.

Conditions

• Pharmacodynamics
• Pharmacokinetics
• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Tegoprazan (C1)	Tegoprazan QD, oral administration. Treatment A
DRUG	Tegoprazan (C1)	Tegoprazan QD, oral administration. Treatment B
DRUG	Treatment C: Tegoprazan (C1)	Tegoprazan BID, oral administration
DRUG	Tegoprazan (C2)	Tegoprazan QD, oral administration, for 7 days. Group 1
DRUG	Tegoprazan (C2)	Tegoprazan QD, oral administration, for 7 days. Group 2
DRUG	Esomeprazole (C2)	Esomeprazole QD, oral administration, for 7 days. Group 3
DRUG	Tegoprazan (C3)	Tegoprazan QD, oral administration

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2018-05-21
• Last updated: 2018-05-21

Locations

1 site across 1 country: South Korea