Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
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 19 kg/m\^2 ≤ BMI \< 28 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 |
|---|---|---|
| AUCt | 0~48hr | Pharmacokinetic evaluation |
| Cmax | 0~48hr | Pharmacokinetic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | 0~48hr | Pharmacokinetic evaluation |
| AUCinf | 0~48hr | Pharmacokinetic evaluation |
| Vd/F | 0~48hr | Pharmacokinetic evaluation |
| CL/F | 0~48hr | Pharmacokinetic evaluation |
| Tmax | 0~48hr | Pharmacokinetic evaluation |
Countries
South Korea
Outcome results
None listed