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

NCT03011996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-12

No results posted yet for this study

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.

Conditions

  • Drug Interaction
  • Pharmacokinetic
  • Pharmacodynamic

Interventions

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

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Jae-Gook Shin · Inje university college of medicine Busan Paik Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011996 on ClinicalTrials.gov