NCT03657472

Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	CJ-30061	Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
DRUG	Exforge® 5/160mg & Lipitor® 20mg	Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg

Timeline

• Start date: 2016-09-19
• Primary completion: 2016-10-29
• Completion: 2016-11-09
• First posted: 2018-09-05
• Last updated: 2018-09-05

Locations

1 site across 1 country: South Korea