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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05548543

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Days)

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 HCP2202 and co-administration of each component in fed condition in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP2202 Drug: RLD2202 Drug: RLD2203	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2202 and Co-administration of RLD2202 and RLD2203 in Healthy Volunteers Under Fed Conditions

Anticipated Study Start Date :

Nov 19, 2022

Anticipated Primary Completion Date :

Dec 18, 2022

Anticipated Study Completion Date :

Dec 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202	Drug: HCP2202 Take it once per period. Drug: RLD2202 Take it once per period. Drug: RLD2203 Take it once per period.
Experimental: Sequence 2 Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203	Drug: HCP2202 Take it once per period. Drug: RLD2202 Take it once per period. Drug: RLD2203 Take it once per period.

Arm

Intervention/Treatment

Experimental: Sequence 1

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

Drug: HCP2202

Take it once per period.

Drug: RLD2202

Take it once per period.

Drug: RLD2203

Take it once per period.

Experimental: Sequence 2

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

Drug: HCP2202

Take it once per period.

Drug: RLD2202

Take it once per period.

Drug: RLD2203

Take it once per period.

Outcome Measures

Primary Outcome Measures

AUCt [0~24 hours]
Pharmacokinetic evaluation
Cmax [0~24 hours]
Pharmacokinetic evaluation

Secondary Outcome Measures

AUCinf [0~24 hours]
Pharmacokinetic evaluation
Tmax [0~24 hours]
Pharmacokinetic evaluation
t1/2 [0~24 hours]
Pharmacokinetic evaluation
CL/F [0~24 hours]
Pharmacokinetic evaluation
Vd/F [0~24 hours]
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 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

Principal Investigator: Mingul Kim, MD, Jeonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT05548543

Other Study ID Numbers:

HM-SARA-103

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

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

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

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Sep 21, 2022