A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

Hanmi Pharmaceutical Company Limited61 enrolled

Overview

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

HCP1701DRUG

Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

HCP1306DRUG

Ezetimibe /Rosuvastatin

HGP0904DRUG

Amlodipine

HGP0608

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 of Amlodipine

Pharmacokinetic evaluation

Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours

AUClast of Amlodipine

Pharmacokinetic evaluation

Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours

Cmax of Losartan

Pharmacokinetic evaluation

Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours

AUClast of Losartan

Pharmacokinetic evaluation

Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours

Cmax of Rosuvastatin

Pharmacokinetic evaluation

Time frame: Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

AUClast of Rosuvastatin

Pharmacokinetic evaluation

Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

Cmax of Free Ezetimibe

Pharmacokinetic evaluation

Time frame: Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

AUClast of Free Ezetimibe

Pharmacokinetic evaluation

Time frame: Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours

Data from ClinicalTrials.gov

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A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes