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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP1007 / omarco and crestor

• Registration Number: NCT01548157
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Study Timeline

• Study First Submitted: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2012-03
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCP1007	HCP1007 / omarco and crestor	HCP1007
omarco and crestor	HCP1007 / omarco and crestor	Rosuvastatin plus Omega-3

Primary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of