NCT01823913

Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Severance Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test formulation	A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg
DRUG	Reference formulation	A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2013-04-04
• Last updated: 2013-04-11

Locations

1 site across 1 country: South Korea