Clinical trial NCT05862090: A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: AUCtau
timeFrame: 0~24 hours after final dose administration
measure: Css,max
timeFrame: 0~24 hours after final dose administration
Secondary outcomes:
measure: Css,min
timeFrame: 0~24 hours after final dose administration
measure: Css,av
timeFrame: 0~24 hours after final dose administration
measure: Tss,max
timeFrame: 0~24 hours after final dose administration
measure: t1/2
timeFrame: 0~24 hours after final dose administration
measure: CLss/F
timeFrame: 0~24 hours after final dose administration
measure: Vdss/F
timeFrame: 0~24 hours after final dose administration
measure: Fluctuation[(Css,max-Css,min)/Css,av]
timeFrame: 0~24 hours after final dose administration
measure: Swing[(Css,max-Css,min)/Css,min]
timeFrame: 0~24 hours after final dose administration
Other outcomes:
measure: Change of Blood Pressure(SBP/DBP) from baseline
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: Change of pulse rate from baseline
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: Change of blood glucose from baseline
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: AUECtau of Blood Pressure(SBP/DBP)
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: AUECtau of pulse rate
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: AUECtau of blood glucose
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: Emax of Blood Pressure(SBP/DBP)
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: Emax of pulse rate
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
measure: Emax of blood glucose
timeFrame: Predose at Day1 and 0~24 hours after final dose administration of each period
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Min-gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: