Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule
June 3, 2013 updated by: Hanmi Pharmaceutical Company Limited
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
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.
Study Overview
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
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Asan Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: HCP1007
|
HCP1007 / Rosuvastatin plus Omega-3
|
|
ACTIVE_COMPARATOR: omarco and crestor
Rosuvastatin plus Omega-3
|
HCP1007 / Rosuvastatin plus Omega-3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: kyun seop Bae, MD, Ph.D, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
February 27, 2012
First Submitted That Met QC Criteria
March 5, 2012
First Posted (ESTIMATE)
March 8, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 4, 2013
Last Update Submitted That Met QC Criteria
June 3, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM-ROMA-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.