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

NCT01823913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-04-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Severance Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01823913 on ClinicalTrials.gov