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

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ClinicalTrials.gov Identifier: NCT01548157
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01548157     History of Changes
Other Study ID Numbers: HM-ROMA-101
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: April 2013

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

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