NCT04587011

A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects

A Phase 1 Clinical Trial to Explore Pharmacokinetics, Pharmacodynamics and Safety After Twice-daily Dosing of Tegoprazan Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.

Detailed description

* To explore the pharmacokinetics, pharmacodynamics and safety in accordance with the dose escalation when tegoprazan is given orally twice daily for 3 days in healthy subjects. * To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tegoprazan dose A or placebo	Tegoprazan A mg or placebo taken orally twice daily for 3 days.
DRUG	Tegoprazan dose B or placebo	Tegoprazan B mg or placebo taken orally twice daily for 3 days.
DRUG	Tegoprazan dose C or placebo	Tegoprazan C mg or placebo taken orally twice daily for 3 days.
DRUG	Tegoprazan dose D or placebo	Tegoprazan D mg or placebo taken orally twice daily for 3 days.

Timeline

• Start date: 2020-09-24
• Primary completion: 2021-03-01
• Completion: 2021-06-01
• First posted: 2020-10-14
• Last updated: 2020-12-28

Locations

1 site across 1 country: South Korea