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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01548157
First received: February 27, 2012
Last updated: June 3, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: HCP1007 / omarco and crestor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCP1007
HCP1007
Drug: HCP1007 / omarco and crestor
HCP1007 / Rosuvastatin plus Omega-3
Active Comparator: omarco and crestor
Rosuvastatin plus Omega-3
Drug: HCP1007 / omarco and crestor
HCP1007 / 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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548157

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: kyun seop Bae, MD, Ph.D Asan Medical Center
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01548157     History of Changes
Other Study ID Numbers: HM-ROMA-101
Study First Received: February 27, 2012
Last Updated: June 3, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
HCP1007
Rosuvastatin
Omega-3

Additional relevant MeSH terms:
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014