Healthy
Conditions
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
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
\[PART A\] 6 x 3 Crossover \[PART B\] Single Arm (Three periods)
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| Css,max | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tss,max | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| t1/2 | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| CLss/F | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| Css,min | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| Fluctuation[(Css,max-Css,min)/Css,av] | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| Swing[(Css,max-Css,min)/Css,min] | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| Vdss/F | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
| Css,av | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration | Pharmacokinetic evaluation |
Countries
South Korea
Outcome results
None listed