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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP1007; Drug: Omarco and Crestor

• Registration Number: NCT01929070
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	HCP1007	* 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
Group 1	Omarco and Crestor	* 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
Group 2	HCP1007	R2 -\> R1 -\> T1 -\> T2
Group 2	Omarco and Crestor	R2 -\> R1 -\> T1 -\> T2
Group 3	Omarco and Crestor	T1 -\> R2 -\> T2 -\> R1
Group 4	Omarco and Crestor	T2 -\> T1 -\> R1 -\> R2
Group 3	HCP1007	T1 -\> R2 -\> T2 -\> R1
Group 4	HCP1007	T2 -\> T1 -\> R1 -\> R2

Primary Outcome Measures

Name	Time	Method
Cmax_adj of DHA and EPA	-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	-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

Name	Time	Method
tmax of DHA and EPA	-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	-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)
AUCinf of DHA and EPA	-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)
Cmax of DHA, EPA	-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	-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	-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)

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of