Back to resultsA Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP2202
RLD2202
RLD2203
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
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
Sites / Locations
- Jeonbuk University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Arm Description
Period 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202
Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203
Outcomes
Primary Outcome Measures
AUCt
Pharmacokinetic evaluation
Cmax
Pharmacokinetic evaluation
Secondary Outcome Measures
AUCinf
Pharmacokinetic evaluation
Tmax
Pharmacokinetic evaluation
t1/2
Pharmacokinetic evaluation
CL/F
Pharmacokinetic evaluation
Vd/F
Pharmacokinetic evaluation
Full Information
NCT ID
NCT05548543
First Posted
September 16, 2022
Last Updated
September 20, 2023
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT05548543
Brief Title
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203
Intervention Type
Drug
Intervention Name(s)
HCP2202
Intervention Description
Take it once per period.
Intervention Type
Drug
Intervention Name(s)
RLD2202
Intervention Description
Take it once per period.
Intervention Type
Drug
Intervention Name(s)
RLD2203
Intervention Description
Take it once per period.
Primary Outcome Measure Information:
Title
AUCt
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
Title
Cmax
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
Secondary Outcome Measure Information:
Title
AUCinf
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
Title
Tmax
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
Title
t1/2
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
Title
CL/F
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
Title
Vd/F
Description
Pharmacokinetic evaluation
Time Frame
0~24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingul Kim, MD
Organizational Affiliation
Jeonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeonbuk University Hospital
City
Jeonju
State/Province
Jeollabuk-do
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
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