NCT01494727

Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are: * To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers * To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CJ Amlodipine/Valsartan 10/160mg	single dose
DRUG	Novartis Exforge 10/160mg	single dose

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-12-19
• Last updated: 2012-05-01

Locations

1 site across 1 country: South Korea