NCT04946903

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

June 23, 2021

Last Update Submit

July 31, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Pharmacokinetic evaluation

    0~48 hour

  • Cmax

    Pharmacokinetic evaluation

    0~48 hour

Secondary Outcomes (5)

  • AUCinf

    0~48 hour

  • Tmax

    0~48 hour

  • t1/2

    0~48 hour

  • CL/F

    0~48 hour

  • Vd/F

    0~48 hour

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902

Drug: RLD2007Drug: RLD2008Drug: HCP1902

Sequence 2

EXPERIMENTAL

Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008

Drug: RLD2007Drug: RLD2008Drug: HCP1902

Interventions

RLD2007DRUG

Take it once per period.

Sequence 1Sequence 2
RLD2008DRUG

Take it once per period.

Sequence 1Sequence 2
HCP1902DRUG

Take it once per period.

Sequence 1Sequence 2

Eligibility Criteria

Age19 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19\~54 years in healthy volunteers 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Study Officials

  • Mingeul Kim

    Jeonbuk University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 1, 2021

Study Start

June 10, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations

KR(1)