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Status unknownNCT02058472Updated Feb 10, 2014

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

A Phase 1 interventional study of G3041 and SEVIKAR® in Healthy Adult Volunteers, sponsored by Dong-A Pharmaceutical Co., Ltd.. Status unknown. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-10.

Sponsored by Dong-A Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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

Phase : Phase I

02

Conditions studied

  • Healthy Adult Volunteers
03

In context

Lead sponsor

Dong-A Pharmaceutical Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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®

Interventions

  • DrugG3041
  • DrugSEVIKAR®
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. ΔAUEC24, ΔEmax, tEmax

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02058472
Lead sponsor
Dong-A Pharmaceutical Co., Ltd.
Collaborators
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Feb 10, 2014
Start date
Dec 2013
Primary completion
May 2014 (estimated)
Completion
May 2014 (estimated)
Last update
Feb 10, 2014

Study contacts

JW Ko, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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