This trial is active, not recruiting.

Condition healthy adult volunteers
Treatments g3041, sevikar®
Phase phase 1
Sponsor Dong-A Pharmaceutical Co., Ltd.
Collaborator Dong-A ST Co., Ltd.
Start date December 2013
End date May 2014
Trial size 30 participants
Trial identifier NCT02058472, G3041_BE_I


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

Phase : Phase I

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Amlodipine orotate 10mg/Olmesartan medoxomil 40mg
(Active Comparator)
Amlodipine besylate 10mg/Olmesartan medoxomil 40mg

Primary Outcomes

AUClast, Cmax
time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 19 years up to 55 years old.

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

Additional Information

Official title 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
Principal investigator JW Ko, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Dong-A Pharmaceutical Co., Ltd..