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

NCT ID: NCT01548157

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCP1007

HCP1007

Group Type EXPERIMENTAL

HCP1007 / omarco and crestor

Intervention Type DRUG

HCP1007 / Rosuvastatin plus Omega-3

omarco and crestor

Rosuvastatin plus Omega-3

Group Type ACTIVE_COMPARATOR

HCP1007 / omarco and crestor

Intervention Type DRUG

HCP1007 / Rosuvastatin plus Omega-3

Interventions

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HCP1007 / omarco and crestor

HCP1007 / Rosuvastatin plus Omega-3

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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kyun seop Bae, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-ROMA-101

Identifier Type: -

Identifier Source: org_study_id

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