NCT03639493

Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

Detailed description

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	Exforge® tab 10/160mg, Crestor® tab 20mg	Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
DRUG	CJ-30060 10/160/20mg	Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg

Timeline

• Start date: 2018-04-06
• Primary completion: 2018-05-04
• Completion: 2018-05-17
• First posted: 2018-08-21
• Last updated: 2018-08-21

Locations

1 site across 1 country: South Korea