Clinical trial NCT06518122: A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers
Official title: A Randomized, Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: \[PART A\] 6 x 3 Crossover

\[PART B\] Single Arm (Three periods)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

Detailed description: \[PART A\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302

\[PART B\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102

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
* 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

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: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: Css,max
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Secondary outcomes:
measure: Css,min
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: Css,av
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: Tss,max
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: t1/2
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: CLss/F
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: Vdss/F
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: Fluctuation[(Css,max-Css,min)/Css,av]
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
measure: Swing[(Css,max-Css,min)/Css,min]
timeFrame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Min-gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: