NCT03011996

To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration

An Open-label, Randomized Study to Evaluate Pharmacokinetic Interaction, Pharmacodynamics and Safety After Multiple Oral Dosing of CJ-12420 and Amoxicillin/Clarithromycin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Cohort 1 To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects. Cohort 2 To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in combination with amoxicillin/clarithromycin in healthy subjects as compared to an active control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.

Detailed description

To evaluate the pharmacokinetic the drug-drug interaction of CJ-12420 and amoxicillin/clarithromycin and investigate the pharmacodynamic of co-administration of CJ-12420 and amoxicillin and clarithromycin.

Conditions

• Drug Interaction
• Pharmacokinetic
• Pharmacodynamic

Interventions

Type	Name	Description
DRUG	CLR 500mg	Cohort 1: bid for 5 days Cohort 2: bid for 7 days
DRUG	CJ-12420 100mg	Cohort 1: bid for 5 days Cohort 2: bid for 7 days
DRUG	CJ-12420 50mg	Cohort 2: bid for 7 days
DRUG	AMX 1g	Cohort 1: bid for 5 days Cohort 2: bid for 7 days
DRUG	Pantoprazole 40mg	Cohort 2: bid for 7 days

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2017-01-06
• Last updated: 2017-05-12

Locations

1 site across 1 country: South Korea