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

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ClinicalTrials.gov Identifier: NCT01929070
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: HCP1007 Drug: Omarco and Crestor Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Male Volunteers
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT01929070


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: JaeWook Ko, M.D. Samsung Medical Center
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01929070    
Other Study ID Numbers: HM-ROMA-103P
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by Hanmi Pharmaceutical Company Limited:
HCP1007
Rosuvastatin
Omega-3
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors