NCT02058472

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

February 6, 2014

Last Update Submit

February 6, 2014

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

  • AUClast, Cmax

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

Secondary Outcomes (2)

  • 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

Study Arms (2)

G3041

EXPERIMENTAL

Amlodipine orotate 10mg/Olmesartan medoxomil 40mg

Drug: G3041Drug: SEVIKAR®

SEVIKAR®

ACTIVE COMPARATOR

Amlodipine besylate 10mg/Olmesartan medoxomil 40mg

Drug: G3041Drug: SEVIKAR®

Interventions

G3041DRUG
G3041SEVIKAR®
SEVIKAR®DRUG
G3041SEVIKAR®

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers between the ages of 19 to 55 years old
  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • JW Ko, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 10, 2014

Study Start

December 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 10, 2014

Record last verified: 2014-02