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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02058472

Enrollment

Registered

2014-02-10

Start date

2013-12-31

Completion date

2014-05-31

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Volunteers

Brief summary

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

Interventions

DRUGG3041

DRUGSEVIKAR®

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026