NCT02387554

Brief Summary

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 12, 2015

Completed
Last Updated

June 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

December 17, 2014

Results QC Date

May 22, 2015

Last Update Submit

June 11, 2015

Conditions

Hypertension(HTN)

Outcome Measures

Primary Outcomes (2)

  • AUClast

    AUClast(Area under the curve to the last measurable concentration)

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

  • Cmax

    Cmax(maxium concentration)

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Secondary Outcomes (5)

  • AUCinf

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

  • Tmax

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

  • T1/2

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

  • CL/F

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

  • Vz/F

    0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

Other Outcomes (1)

  • Number of Paticipants With Adverse Events

    3 months

Study Arms (4)

HGP0904+HGP0608+HGP1405

EXPERIMENTAL

amlodipine + losartan + chlorthalidone

Drug: HGP0904Drug: HGP0608Drug: HGP1405

HGP0904

ACTIVE COMPARATOR

amlodipine

Drug: HGP0904

HGP0608

ACTIVE COMPARATOR

losartan

Drug: HGP0608

HGP1405

ACTIVE COMPARATOR

chlorthalidone

Drug: HGP1405

Interventions

HGP0904DRUG
Also known as: amlodipine
HGP0904HGP0904+HGP0608+HGP1405
HGP0608DRUG
Also known as: losartan
HGP0608HGP0904+HGP0608+HGP1405
HGP1405DRUG
Also known as: chlorthalidone
HGP0904+HGP0608+HGP1405HGP1405

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \~45 years old
  • Healthy men

You may not qualify if:

  • Gastroentestinal disease affecting drug absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

AmlodipineLosartanChlorthalidone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesTetrazolesBenzenesulfonamidesSulfonamidesAmidesBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Principal Investigator
Organization
Bundang Seoul National University Hospital
mekka@snu.ac.kr

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

December 17, 2014

First Posted

March 13, 2015

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 12, 2015

Results First Posted

June 12, 2015

Record last verified: 2015-05

Locations

KR(1)