Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition 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 * 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg * 90 mmHg ≤ sitSBP \<140 mmHg, 50 mmHg ≤ sitDBP \<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 cannot consume the high-fat meal provided during this clinical trial * Subjects who judged ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt | 0~48 hours | Pharmacokinetic evaluation |
| Cmax | 0~48 hours | Pharmacokinetic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | 0~48 hours | Pharmacokinetic evaluation |
| AUCinf | 0~48 hours | Pharmacokinetic evaluation |
| Vd/F | 0~48 hours | Pharmacokinetic evaluation |
| CL/F | 0~48 hours | Pharmacokinetic evaluation |
| Tmax | 0~48 hours | Pharmacokinetic evaluation |
Countries
South Korea
Outcome results
None listed