Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule

A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548157

Enrollment

Registered

2012-03-08

Start date

2012-03-31

Completion date

2012-12-31

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

HCP1007, Rosuvastatin, Omega-3

Brief summary

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

Detailed description

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

Interventions

DRUGHCP1007 / omarco and crestor

HCP1007 / Rosuvastatin plus Omega-3

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Area Under Curve(AUC) last	0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026