A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers
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
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2021
Longer than P75 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 28, 2021
CompletedFirst Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2022
CompletedSeptember 22, 2023
September 1, 2023
1.2 years
December 1, 2021
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
AUCt
Pharmacokinetic evaluation
0~48hr
Cmax
Pharmacokinetic evaluation
0~48hr
Secondary Outcomes (5)
AUCinf
0~48hr
Tmax
0~48hr
t1/2
0~48hr
CL/F
0~48hr
Vd/F
0~48hr
Study Arms (4)
Sequence 1
EXPERIMENTALPeriod 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001
Sequence 2
EXPERIMENTALPeriod 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
Sequence 3
EXPERIMENTALPeriod 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001
Sequence 4
EXPERIMENTALPeriod 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
Interventions
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Mingeul Kim
Chonbuk 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
December 1, 2021
First Posted
December 14, 2021
Study Start
September 28, 2021
Primary Completion
November 27, 2022
Study Completion
November 27, 2022
Last Updated
September 22, 2023
Record last verified: 2023-09