A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203
An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Aug 2022
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
First Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
August 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2022
CompletedSeptember 22, 2023
September 1, 2023
3 months
July 29, 2022
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Cmax,ss of RLD2202
Pharmacokinetic evaluation
0~24 hours
AUCtau,ss of RLD2202
Pharmacokinetic evaluation
0~24 hours
Cmax,ss of RLD2203
Pharmacokinetic evaluation
0~24 hours
AUCtau,ss of RLD2203
Pharmacokinetic evaluation
0~24 hours
Inhibition of Platelet Aggregation(%)
Pharmacodynamic evaluation
0~6 days
Inhibition of Thromboxane B2(%)
Pharmacodynamic evaluation
0~6 days
Secondary Outcomes (7)
Tmax,ss of RLD2202 and RLD2203
0~24 hours
t1/2,ss of RLD2202 and RLD2203
0~24 hours
Cmin,ss of RLD2202 and RLD2203
0~24 hours
Cavg,ss of RLD2202 and RLD2203
0~24 hours
CLss/F of RLD2202 and RLD2203
0~24 hours
- +2 more secondary outcomes
Study Arms (1)
Fixed Sequence
EXPERIMENTALPeriod 1: RLD2202, Period 2 : RLD2203 -\> RLD2202+RLD2203
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults in the age between 19 and 50 years old
- Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
- After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
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)
Seoul National University Hospital
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
SeungHwan Lee, M.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 1, 2022
Study Start
August 2, 2022
Primary Completion
October 25, 2022
Study Completion
October 25, 2022
Last Updated
September 22, 2023
Record last verified: 2023-09