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Bioequivalence Study of CJ-30060 in Healthy Volunteers

NCT03757390 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-11-28

No results posted yet for this study

Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.

Conditions

  • Healthy Subjects

Interventions

DRUG

Exforge® tab 5/160mg, Crestor® tab 10mg

co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg

DRUG

CJ-30060 5/160/10mg

Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Ji Young Park, PhD · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2018-12-14
Completion
2018-12-14

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 NCT03757390 on ClinicalTrials.gov