NCT01447797

Brief Summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 3, 2012

Status Verified

September 1, 2011

Enrollment Period

2 months

First QC Date

September 28, 2011

Last Update Submit

April 1, 2012

Conditions

Healthy

Keywords

IrbesartanAtorvastatincombination

Outcome Measures

Primary Outcomes (4)

  • AUC of Irbesartan

    0-48 hrs

  • AUC of Atorvastatin and 2-hydroxy atorvastatin

    0-48 hrs

  • Cmax of Irbesartan

    0-48 hrs

  • Cmax of Atorvastatin and 2-hydroxy atorvastatin

    0-48 hrs

Study Arms (2)

HCP0912

EXPERIMENTAL

Irbesartan/Atorvastatin combination tablet

Drug: HCP0912 / Irbesartan and Atorvastatin

Irbesartan and Atorvastatin

ACTIVE COMPARATOR

coadministration of irbesartan and atorvastatin

Drug: HCP0912 / Irbesartan and Atorvastatin

Interventions

HCP0912 / Irbesartan and AtorvastatinDRUG

Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

HCP0912Irbesartan and Atorvastatin

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 45
  • Signed informed consent form
  • weight : over 45kg and in the range of ±20% of IBW

You may not qualify if:

  • Has a medical history of hypersensitivity to atorvastatin or irbesartan
  • severe Hypotension
  • Not eligible for subject in health examination within 28 days of IP administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

IrbesartanAtorvastatin

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsPyrrolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ji-Young Park, MD, PhD

    Korea University Anam Hospital

    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

September 28, 2011

First Posted

October 6, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

April 3, 2012

Record last verified: 2011-09

Locations

KR(1)