A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers
- Registration Number
- NCT05862090
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 (First RLD2301, then RLD2301+RLD2007) RLD2301 Period1 : RLD2301 Period2 : RLD2301 + RLD2007 Arm 2 (First RLD2007, then RLD2301+RLD2007) RLD2301 Period1 : RLD2007 Period2 : RLD2301 + RLD2007 Arm 2 (First RLD2007, then RLD2301+RLD2007) RLD2007 Period1 : RLD2007 Period2 : RLD2301 + RLD2007 Arm 1 (First RLD2301, then RLD2301+RLD2007) RLD2007 Period1 : RLD2301 Period2 : RLD2301 + RLD2007
- Primary Outcome Measures
Name Time Method AUCtau 0~24 hours after final dose administration Pharmacokinetic evaluation
Css,max 0~24 hours after final dose administration Pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method Swing[(Css,max-Css,min)/Css,min] 0~24 hours after final dose administration Pharmacokinetic evaluation
Css,min 0~24 hours after final dose administration Pharmacokinetic evaluation
t1/2 0~24 hours after final dose administration Pharmacokinetic evaluation
Fluctuation[(Css,max-Css,min)/Css,av] 0~24 hours after final dose administration Pharmacokinetic evaluation
Css,av 0~24 hours after final dose administration Pharmacokinetic evaluation
Tss,max 0~24 hours after final dose administration Pharmacokinetic evaluation
CLss/F 0~24 hours after final dose administration Pharmacokinetic evaluation
Vdss/F 0~24 hours after final dose administration Pharmacokinetic evaluation
Trial Locations
- Locations (1)
Jeonbuk University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of