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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1007; Drug: Omarco and Crestor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01929070

HM-ROMA-103P

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Group 1

Experimental group

Description:

* 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

Treatment:

Drug: HCP1007

Drug: Omarco and Crestor

Group 2

Experimental group

Description:

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

Treatment:

Drug: HCP1007

Drug: Omarco and Crestor

Group 3

Experimental group

Description:

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

Treatment:

Drug: HCP1007

Drug: Omarco and Crestor

Group 4

Experimental group

Description:

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

Treatment:

Drug: HCP1007

Drug: Omarco and Crestor