NCT01548157

Brief Summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2012

Typical duration for phase_1 healthy

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

First Submitted

Initial submission to the registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 4, 2013

Status Verified

April 1, 2013

Enrollment Period

Same day

First QC Date

February 27, 2012

Last Update Submit

June 3, 2013

Conditions

Healthy

Keywords

HCP1007RosuvastatinOmega-3

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve(AUC) last

    0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose

Study Arms (2)

HCP1007

EXPERIMENTAL

HCP1007

Drug: HCP1007 / omarco and crestor

omarco and crestor

ACTIVE COMPARATOR

Rosuvastatin plus Omega-3

Drug: HCP1007 / omarco and crestor

Interventions

HCP1007 / omarco and crestorDRUG

HCP1007 / Rosuvastatin plus Omega-3

HCP1007omarco and crestor

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteers, age between 20 and 45
  • Informed of the investigational nature of this study and voluntarily agree to participate in this study
  • BMI of \>20kg/m2 and \<26kg/m2 subject

You may not qualify if:

  • Use of any prescription medication within 14 days prior to Day 1
  • Use of any medication within 7 days prior to Day 1
  • Participation in another clinical study within 60 days prior to start of study drug administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • kyun seop Bae, MD, Ph.D

    Asan 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 27, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

June 4, 2013

Record last verified: 2013-04

Locations

KR(1)