NCT07277712

A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers

Detailed description

A randomized, open-label, crossover study \[Part A\] To evaluate and compare the pharmacokinetic and safety of co-administration of tegoprazan and naproxen versus administration of IN-M00002 tablet in healthy adult volunteers \[Part B\] To evaluate the effects of food on the pharmacokinetic and safety of IN-M00002 tablet in healthy adult volunteers

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Tegoprazan	Tegoprazan 25 mg QD
DRUG	Naproxen	Naproxen 500 mg BID
DRUG	IN-M00002	IN-M00002 tablet QD
DRUG	IN-M00002	IN-M00002 tablet BID

Timeline

• Start date: 2025-12-27
• Primary completion: 2026-05-30
• Completion: 2026-09-30
• First posted: 2025-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: South Korea