Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01548157
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP1007 / omarco and crestor	Phase 1

Detailed Description

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCP1007 HCP1007	Drug: HCP1007 / omarco and crestor; HCP1007 / Rosuvastatin plus Omega-3
Active Comparator: omarco and crestor Rosuvastatin plus Omega-3	Drug: HCP1007 / omarco and crestor; HCP1007 / Rosuvastatin plus Omega-3

Outcome Measures

Primary Outcome Measures

1. Area Under Curve(AUC) last [0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male volunteers, age between 20 and 45

• Informed of the investigational nature of this study and voluntarily agree to participate in this study

• BMI of >20kg/m2 and <26kg/m2 subject

Exclusion Criteria:

• Use of any prescription medication within 14 days prior to Day 1

• Use of any medication within 7 days prior to Day 1

• Participation in another clinical study within 60 days prior to start of study drug administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Principal Investigator: kyun seop Bae, MD, Ph.D, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT01548157
• Other Study ID Numbers: HM-ROMA-101
• First Posted: Mar 8, 2012
• Last Update Posted: Jun 4, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Hanmi Pharmaceutical Company Limited: HCP1007; Rosuvastatin; Omega-3
• Additional relevant MeSH terms: Rosuvastatin Calcium

Study Results

No Results Posted as of Jun 4, 2013