A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-05-14

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.

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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

* Period 1, Period 3: RLD2205 + RLD2206
* Period 2, Period 4: HCP2201

Group Type EXPERIMENTAL

HCP2201

Intervention Type DRUG

Take 2 tablets once per period

RLD2205

Intervention Type DRUG

Take 2 tablets once per period

RLD2206

Intervention Type DRUG

Take 1 tablet once per period

Sequence 2

* Period 1, Period 3: HCP2201
* Period 2, Period 4: RLD2205 + RLD2206

Group Type EXPERIMENTAL

HCP2201

Intervention Type DRUG

Take 2 tablets once per period

RLD2205

Intervention Type DRUG

Take 2 tablets once per period

RLD2206

Intervention Type DRUG

Take 1 tablet once per period

Interventions

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HCP2201

Take 2 tablets once per period

Intervention Type DRUG

RLD2205

Take 2 tablets once per period

Intervention Type DRUG

RLD2206

Take 1 tablet once per period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19\~55 years in healthy male volunteers
* 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight ≥55kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria

* 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
* Subjects who judged ineligible by the investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes