NCT01929070

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 2013

Shorter than P25 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

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
Last Updated

March 10, 2014

Status Verified

March 1, 2014

Enrollment Period

28 days

First QC Date

March 14, 2013

Last Update Submit

March 7, 2014

Conditions

Healthy

Keywords

HCP1007RosuvastatinOmega-3

Outcome Measures

Primary Outcomes (2)

  • Cmax_adj of DHA and EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)

  • AUClast_adj of DHA and EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)

Secondary Outcomes (6)

  • Cmax of DHA, EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)

  • AUClast of DHA, EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)

  • AUClast of DHA and EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)

  • tmax of DHA and EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)

  • t1/2 of DHA and EPA

    -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)

  • +1 more secondary outcomes

Study Arms (4)

Group 1

EXPERIMENTAL

* R1: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap in the fasting state * R2: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap on the high-fat diet * T1: Single-dose of HCP1007 1g/5mg 4 cap in the fasting state * T2: Single-dose of HCP1007 1g/5mg 4 cap on the high-fat diet R1 -\> T2 -\> R2 -\> T1

Drug: HCP1007Drug: Omarco and Crestor

Group 2

EXPERIMENTAL

R2 -\> R1 -\> T1 -\> T2

Drug: HCP1007Drug: Omarco and Crestor

Group 3

EXPERIMENTAL

T1 -\> R2 -\> T2 -\> R1

Drug: HCP1007Drug: Omarco and Crestor

Group 4

EXPERIMENTAL

T2 -\> T1 -\> R1 -\> R2

Drug: HCP1007Drug: Omarco and Crestor

Interventions

HCP1007DRUG
Group 1Group 2Group 3Group 4
Omarco and CrestorDRUG
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male aged 20 to 55 years
  • A body mass index between 19 and 27 kg/m2

You may not qualify if:

  • History of hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic or cardiovascular disease
  • SBP \< 90 or ≥ 150 mmHg, DBP \< 60 or ≥90 mmHg
  • Use of herbal medicine within 30 days, prescriptive medicine within 14 days, or over-the-counter drug within 7 days
  • Heavy alcohol consumption (140 g/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung 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

  • JaeWook Ko, M.D.

    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

March 14, 2013

First Posted

August 27, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 10, 2014

Record last verified: 2014-03

Locations

KR(1)