A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05155995

Collaborator

(none)

Enrollment

Location

Arms

2.6

Anticipated Duration (Months)

27.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP2001 Drug: RLD2007 Drug: RLD2008 Drug: RLD2102	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers

Actual Study Start Date :

Oct 21, 2021

Anticipated Primary Completion Date :

Jan 7, 2022

Anticipated Study Completion Date :

Jan 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001	Drug: HCP2001 Take it once per period. Drug: RLD2007 Take it once per period. Drug: RLD2008 Take it once per period. Drug: RLD2102 Take it once per period.
Experimental: Sequence 2 Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102	Drug: HCP2001 Take it once per period. Drug: RLD2007 Take it once per period. Drug: RLD2008 Take it once per period. Drug: RLD2102 Take it once per period.
Experimental: Sequence 3 Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001	Drug: HCP2001 Take it once per period. Drug: RLD2007 Take it once per period. Drug: RLD2008 Take it once per period. Drug: RLD2102 Take it once per period.
Experimental: Sequence 4 Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102	Drug: HCP2001 Take it once per period. Drug: RLD2007 Take it once per period. Drug: RLD2008 Take it once per period. Drug: RLD2102 Take it once per period.

Outcome Measures

Primary Outcome Measures

AUCt [0~48hr]
Pharmacokinetic evaluation
Cmax [0~48hr]
Pharmacokinetic evaluation

Secondary Outcome Measures

AUCinf [0~48hr]
Pharmacokinetic evaluation
Tmax [0~48hr]
Pharmacokinetic evaluation
t1/2 [0~48hr]
Pharmacokinetic evaluation
CL/F [0~48hr]
Pharmacokinetic evaluation
Vd/F [0~48hr]
Pharmacokinetic evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 54 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

Principal Investigator: Mingeul Kim, Chonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT05155995

Other Study ID Numbers:

HM-DATAM-101

First Posted:

Dec 14, 2021

Last Update Posted:

Dec 14, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 14, 2021