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CompletedNCT01929070Updated Mar 10, 2014

A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007

A Phase 1 interventional study of HCP1007 and Omarco and Crestor in Healthy, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-10.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • HCP1007
  • Rosuvastatin
  • Omega-3
03

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult male aged 20 to 55 years
  • A body mass index between 19 and 27 kg/m2

Exclusion criteria

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Group 1

    * R1: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap in the fasting state * R2: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap on the high-fat diet * T1: Single-dose of HCP1007 1g/5mg 4 cap in the fasting state * T2: Single-dose of HCP1007 1g/5mg 4 cap on the high-fat diet R1 -\> T2 -\> R2 -\> T1

    Drug: HCP1007 · Drug: Omarco and Crestor

  • Experimental
    Group 2

    R2 -\> R1 -\> T1 -\> T2

    Drug: HCP1007 · Drug: Omarco and Crestor

  • Experimental
    Group 3

    T1 -\> R2 -\> T2 -\> R1

    Drug: HCP1007 · Drug: Omarco and Crestor

  • Experimental
    Group 4

    T2 -\> T1 -\> R1 -\> R2

    Drug: HCP1007 · Drug: Omarco and Crestor

Interventions

  • DrugHCP1007
  • DrugOmarco and Crestor
06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

07

Study locations

1 site
  • Samsung medical center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01929070
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Aug 27, 2013
Start date
Feb 2013
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Mar 10, 2014

Study contacts

JaeWook Ko, M.D.
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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