Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

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

Phase : Phase I

Study Overview

• Status: Unknown
• Conditions: Healthy Adult Volunteers
• Intervention / Treatment: Drug: G3041; Drug: SEVIKAR®

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers between the ages of 19 to 55 years old
• 19 ≤ BMI ≤ 27
• 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 olmesartan
• Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
• Excessive drinking(exceed alcohol 140g/week)
• Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
• Smoking over 10 cigarettes per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G3041; Amlodipine orotate 10mg/Olmesartan medoxomil 40mg	Drug: G3041; Drug: SEVIKAR®
Active Comparator: SEVIKAR®; Amlodipine besylate 10mg/Olmesartan medoxomil 40mg	Drug: G3041; Drug: SEVIKAR®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast, Cmax	Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax, t1/2, AUCinf, CL/F, Vz/F	Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
ΔAUEC24, ΔEmax, tEmax	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Collaborators: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: JW Ko, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Estimate): February 10, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: G3041_BE_I