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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1007 / omarco and crestor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01548157

HM-ROMA-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 28 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

HCP1007

Experimental group

Description:

HCP1007

Treatment:

Drug: HCP1007 / omarco and crestor

omarco and crestor

Active Comparator group

Description:

Rosuvastatin plus Omega-3

Treatment:

Drug: HCP1007 / omarco and crestor