Healthy Volunteers
Conditions
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.
Interventions
DRUGRLD2301
Take it once a day per period.
DRUGRLD2007
Take it once a day per period.
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 54 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau | 0~24 hours after final dose administration | Pharmacokinetic evaluation |
| Css,max | 0~24 hours after final dose administration | Pharmacokinetic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Css,min | 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 |
| t1/2 | 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 |
| Fluctuation[(Css,max-Css,min)/Css,av] | 0~24 hours after final dose administration | Pharmacokinetic evaluation |
| Swing[(Css,max-Css,min)/Css,min] | 0~24 hours after final dose administration | Pharmacokinetic evaluation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of pulse rate from baseline | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| Change of blood glucose from baseline | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| AUECtau of Blood Pressure(SBP/DBP) | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| AUECtau of pulse rate | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| AUECtau of blood glucose | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| Emax of Blood Pressure(SBP/DBP) | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| Emax of pulse rate | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| Emax of blood glucose | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
| Change of Blood Pressure(SBP/DBP) from baseline | Predose at Day1 and 0~24 hours after final dose administration of each period | Pharmacodynamic evaluation |
Countries
South Korea
Outcome results
None listed