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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2019-02-13

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1 (Reference-Test)

Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701

Group Type EXPERIMENTAL

HCP1701

Intervention Type DRUG

Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

HCP1306

Intervention Type DRUG

Ezetimibe /Rosuvastatin

HGP0904

Intervention Type DRUG

Amlodipine

HGP0608

Intervention Type DRUG

Losartan potassium

Sequence 2 (Test-Reference)

Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608

Group Type EXPERIMENTAL

HCP1701

Intervention Type DRUG

Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

HCP1306

Intervention Type DRUG

Ezetimibe /Rosuvastatin

HGP0904

Intervention Type DRUG

Amlodipine

HGP0608

Intervention Type DRUG

Losartan potassium

Interventions

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HCP1701

Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

Intervention Type DRUG

HCP1306

Ezetimibe /Rosuvastatin

Intervention Type DRUG

HGP0904

Amlodipine

Intervention Type DRUG

HGP0608

Losartan potassium

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes