A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007
March 7, 2014 updated by: Hanmi Pharmaceutical Company Limited
A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
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
- Samsung 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 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Adult male aged 20 to 55 years
- A body mass index between 19 and 27 kg/m2
Exclusion Criteria:
- History of hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic or cardiovascular disease
- SBP < 90 or ≥ 150 mmHg, DBP < 60 or ≥90 mmHg
- Use of herbal medicine within 30 days, prescriptive medicine within 14 days, or over-the-counter drug within 7 days
- Heavy alcohol consumption (140 g/day)
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group 1
R1 -> T2 -> R2 -> T1 |
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Experimental: Group 2
R2 -> R1 -> T1 -> T2
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Experimental: Group 3
T1 -> R2 -> T2 -> R1
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Experimental: Group 4
T2 -> T1 -> R1 -> R2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cmax_adj of DHA and EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
|
|
AUClast_adj of DHA and EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cmax of DHA, EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
|
AUClast of DHA, EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
|
AUClast of DHA and EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
|
tmax of DHA and EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
|
t1/2 of DHA and EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
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|
AUCinf of DHA and EPA
Time Frame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
-24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: JaeWook Ko, M.D., Samsung 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
February 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 14, 2013
First Submitted That Met QC Criteria
August 22, 2013
First Posted (Estimate)
August 27, 2013
Study Record Updates
Last Update Posted (Estimate)
March 10, 2014
Last Update Submitted That Met QC Criteria
March 7, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM-ROMA-103P
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.