Healthy
Conditions
Brief summary
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
Detailed description
pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
Interventions
DRUGNVP-1805
orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)
orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)
Sponsors
NVP Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult subjects who signed informed consent * BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)
Exclusion criteria
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug * Inadequate subject for the clinical trial by the investigator's decision * Subjects participated in another clinical trial within 6 months prior to administration of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of plasma: AUClast | 0hours - 72hours |
| Pharmacokinetics of plasma: Cmax | 0hours - 72hours |
Countries
South Korea
Outcome results
None listed