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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Test formulation; Drug: Reference formulation

• Registration Number: NCT01823913
• Lead Sponsor: Severance Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-03-30
• Status Verified: 2013-04
• Study First Posted: 2013-04-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria

• History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
• Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
• Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
• Use of any substance that could induce or inhibit drug metabolism enzymes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test and reference formulations	Test formulation	Test formulation and reference formulation given orally 14 days apart in a fasted state
Test and reference formulations	Reference formulation	Test formulation and reference formulation given orally 14 days apart in a fasted state

Primary Outcome Measures

Name	Time	Method
Profile of Pharmacokinetics	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose	Cmax, Area Under Curve(0 to the last sampling time)

Secondary Outcome Measures

Name	Time	Method
Profile of Pharmacokinetics	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose	Tmax, Area Under Curve(0 to infinity), T_1/2

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of