A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2021-08-10

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 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: Fasted state + RLD2007 +RLD2008,

Period 2: Fasted state + HCP1902

Group Type EXPERIMENTAL

RLD2007

Intervention Type DRUG

Take it once per period.

RLD2008

Intervention Type DRUG

Take it once per period.

HCP1902

Intervention Type DRUG

Take it once per period.

Sequence 2

Period 1: Fasted state + HCP1902,

Period 2: Fasted state + RLD2007 + RLD2008

Group Type EXPERIMENTAL

RLD2007

Intervention Type DRUG

Take it once per period.

RLD2008

Intervention Type DRUG

Take it once per period.

HCP1902

Intervention Type DRUG

Take it once per period.

Interventions

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RLD2007

Take it once per period.

Intervention Type DRUG

RLD2008

Take it once per period.

Intervention Type DRUG

HCP1902

Take it once per period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19\~54 years in healthy volunteers 19 kg/m\^2 ≤ BMI \< 28 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