A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteer
• Intervention / Treatment: Drug: Exforge®; Drug: G-0081

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
• having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
• doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria:

• Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
• Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
• Gastrointestinal diseases or surgeries that affect absorption of drug
• Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
• Smoking over 10 cigarettes per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg); Exforge® 10/160	Drug: Exforge®
EXPERIMENTAL: G-0081 (Amlodipine orotate 10mg / Valsratan 160mg); G-0081	Drug: G-0081

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast, Cmax	Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf, Tmax, t1/2, % AUCextra	AUCinf = AUClast + Clast/λz %AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100 t1/2 = 0.693/λz	Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: K S Park, MD, PhD, Head of Clinical Development, Clinical Trials Center Severance Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (ESTIMATE): January 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Amlodipine, Valsartan Drug Combination
• Other Study ID Numbers: G-0081_BA_I