A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy 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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-02

Study Completion Date

2022-11-10

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fasting condition in healthy 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: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202

Group Type EXPERIMENTAL

HCP2202

Intervention Type DRUG

Take it once per period.

RLD2202

Intervention Type DRUG

Take it once per period.

RLD2203

Intervention Type DRUG

Take it once per period.

Sequence 2

Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203

Group Type EXPERIMENTAL

HCP2202

Intervention Type DRUG

Take it once per period.

RLD2202

Intervention Type DRUG

Take it once per period.

RLD2203

Intervention Type DRUG

Take it once per period.

Interventions

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HCP2202

Take it once per period.

Intervention Type DRUG

RLD2202

Take it once per period.

Intervention Type DRUG

RLD2203

Take it once per period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19\~54 years in healthy volunteers 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 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 or eggs 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

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes