A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers
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 or Co-administration of RLD2202 and RLD2203 in Healthy Volunteers Under Fasting Conditions
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fasting condition in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2022
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2022
CompletedFirst Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2022
CompletedSeptember 22, 2023
September 1, 2022
2 months
September 6, 2022
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
AUCt
Pharmacokinetic evaluation
0~24 hours
Cmax
Pharmacokinetic evaluation
0~24 hours
Secondary Outcomes (5)
AUCinf
0~24 hours
Tmax
0~24 hours
t1/2
0~24 hours
CL/F
0~24 hours
Vd/F
0~24 hours
Study Arms (2)
Sequence 1
EXPERIMENTALPeriod 1: RLD2202 +RLD2203 Period 2: HCP2202 Period 3: RLD2202 +RLD2203 Period 4: HCP2202
Sequence 2
EXPERIMENTALPeriod 1: HCP2202 Period 2: RLD2202 +RLD2203 Period 3: HCP2202 Period 4: RLD2202 +RLD2203
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~54 years in healthy volunteers 18.5 kg/m\^2 ≤ BMI \< 30 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
Study Officials
- PRINCIPAL INVESTIGATOR
Mingul Kim, MD
Jeonbuk National University Hospital
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
September 6, 2022
First Posted
September 21, 2022
Study Start
September 2, 2022
Primary Completion
November 10, 2022
Study Completion
November 10, 2022
Last Updated
September 22, 2023
Record last verified: 2022-09