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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP1007 / omarco and crestor

Drug

HCP1007 / Rosuvastatin plus Omega-3

Primary outcomes

Area Under Curve(AUC) last

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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 8, 2012
Registry last updated: Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed