A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.

Hanmi Pharmaceutical Company Limited31 enrolled

Overview

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

HCP1306DRUG

Ezetimibe 10mg / Rosuvastatin 20mg (Rosuzet)

HGP0904DRUG

Amlodipine 5mg(Norvasc)

HGP0608DRUG

Losartan 100mg(Cozaar)

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 19\~45 years in healthy volunteers 2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2 3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm. 4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: 1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system 2. Subjects who judged ineligible by the investigator

Locations (1)

Korea University Hospital (Anam)

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax,ss of Amlodipine

Pharmacokinetic evaluation

Time frame: D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

AUCtau of Amlodipine

Pharmacokinetic evaluation

Cmax,ss of Losartan

Pharmacokinetic evaluation

AUCtau of Losartan

Pharmacokinetic evaluation

Cmax,ss of EXP3174

Pharmacokinetic evaluation

AUCtau of EXP3174

Pharmacokinetic evaluation

Data from ClinicalTrials.gov

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Secondary Outcomes

Cmin,ss of Amlodipine

Pharmacokinetic evaluation

T max,ss of Amlodipine

Pharmacokinetic evaluation

T1/2 of Amlodipine

Pharmacokinetic evaluation

Cmin,ss of Losartan

Pharmacokinetic evaluation

T max,ss of Losartan

Pharmacokinetic evaluation

T1/2 of Losartan

Pharmacokinetic evaluation

Cmin,ss of EXP3174

Pharmacokinetic evaluation

T max,ss of EXP3174

Pharmacokinetic evaluation

T1/2 of EXP3174

Pharmacokinetic evaluation

Cmin,ss of Rosuvastatin

Pharmacokinetic evaluation

Time frame: D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

T max,ss of Rosuvastatin

Pharmacokinetic evaluation

T1/2 of Rosuvastatin

Pharmacokinetic evaluation

Cmin,ss of Free Ezetimibe

Pharmacokinetic evaluation

Time frame: D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

Tmax,ss of Free Ezetimibe

Pharmacokinetic evaluation

T1/2 of Free Ezetimibe

Pharmacokinetic evaluation

Cmin,ss of Total Ezetimibe

Pharmacokinetic evaluation

Tmax,ss of Total Ezetimibe

Pharmacokinetic evaluation

T1/2 of Total Ezetimibe

Pharmacokinetic evaluation