NCT03043521

Pharmacodynamic Properties of CJ-12420 on Evening Dosing

Phase I Study to Investigate Pharmacodynamics of CJ-12420 Compared to Dexlansoprazole With Evening Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare and evaluate impact on pharmacodynamic characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male volunteers

Detailed description

Evaluation Criteria: 1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420 2. Pharmacodynamics Endpoints Time pH \> 4 Time pH \> 6 Integrated acidity Percent inhibition of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH 3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate, body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dexlansoprazole 60 MG
DRUG	CJ-12420 50mg
DRUG	CJ-12420 100mg
DRUG	CJ-12420 200mg

Timeline

• Start date: 2015-05-13
• Primary completion: 2015-08-12
• Completion: 2015-08-12
• First posted: 2017-02-06
• Last updated: 2017-02-06

Locations

1 site across 1 country: South Korea