Completed
Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
What is being tested
Test formulation
+ Reference formulation
Drug
Who is being recruted
From 20 to 50 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: July 2012
Summary
Principal SponsorSeverance Hospital
Last updated: April 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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
Principal SponsorSeverance Hospital
Last updated: April 11, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 20 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
1 inclusion criteria required to participate
Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
4 exclusion criteria prevent from participating
Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests
History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease
Use of any substance that could induce or inhibit drug metabolism enzymes
Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTest formulation and reference formulation given orally 14 days apart in a fasted state
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center