NCT06332638

PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

Phase 1 Clinical Trial to Explore Pharmacokinetics, Pharmacodynamics and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily.

Detailed description

The secondary objectives of this study are * To compare pharmacokinetics and pharmacodynamics of tegoprazan 12.5 mg in healthy subjects between oral multiple-dose administration twice daily for 1 day and oral single-dose administration. * To evaluate pharmacokinetics and pharmacodynamics of tegoprazan 12.5 mg administered orally twice daily for 14 days in healthy subjects in comparison with tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects. * To evaluate pharmacodynamics of tegoprazan 12.5 mg administered orally twice daily for 14 days or tegoprazan 25 mg administered orally once daily for 14 days in healthy subjects in comparison with famotidine 20 mg administered orally twice daily for 14 days in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tegoprazan 12.5mg	Oral administration of one tablet of Tegoprazan 12.5mg twice daily for 14 days.
DRUG	Tegoprazan 25mg	Oral administration of one tablet of Tegoprazan 25mg once daily for 14 days.
DRUG	Famotidine 20mg	Oral administration of one tablet of Famotidine 20mg twice daily for 14 days.

Timeline

• Start date: 2024-03-19
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: South Korea