A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers
An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration 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-volunteers
Started Apr 2023
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2023
CompletedFirst Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2023
CompletedSeptember 22, 2023
September 1, 2023
2 months
May 8, 2023
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
AUCtau
Pharmacokinetic evaluation
0~24 hours after final dose administration
Css,max
Pharmacokinetic evaluation
0~24 hours after final dose administration
Secondary Outcomes (8)
Css,min
0~24 hours after final dose administration
Css,av
0~24 hours after final dose administration
Tss,max
0~24 hours after final dose administration
t1/2
0~24 hours after final dose administration
CLss/F
0~24 hours after final dose administration
- +3 more secondary outcomes
Other Outcomes (9)
Change of Blood Pressure(SBP/DBP) from baseline
Predose at Day1 and 0~24 hours after final dose administration of each period
Change of pulse rate from baseline
Predose at Day1 and 0~24 hours after final dose administration of each period
Change of blood glucose from baseline
Predose at Day1 and 0~24 hours after final dose administration of each period
- +6 more other outcomes
Study Arms (2)
Arm 1 (First RLD2301, then RLD2301+RLD2007)
EXPERIMENTALPeriod1 : RLD2301 Period2 : RLD2301 + RLD2007
Arm 2 (First RLD2007, then RLD2301+RLD2007)
EXPERIMENTALPeriod1 : RLD2007 Period2 : RLD2301 + RLD2007
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~54 years in healthy volunteers
- kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
- mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
- 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)
Jeonbuk University Hospital
Jeonju, Jeollabuk-do, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Min-gul Kim, MD
Jeonbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 17, 2023
Study Start
April 5, 2023
Primary Completion
May 26, 2023
Study Completion
May 26, 2023
Last Updated
September 22, 2023
Record last verified: 2023-09