Healthy
Conditions
Brief summary
The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.
Detailed description
This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.
Interventions
DRUGNVP-1402
Oral
DRUGNVP-1402R
Oral
Sponsors
NVP Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy males * No history of clinically significant medical disorder * Capable of consent to participate in the study
Exclusion criteria
* History of hypersensitive reactions to study drug or other related drugs * Any significant abnormality found during screening * Any significant medical history * History of alcohol abuse, smoking continuously * History of drug abuse * Clinically significant surgery within 4 weeks prior to administration of the study drug * Participation in another clinical trial within 3 months prior to administration of the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of plasma: Cmax | up to 24 hours after administration | Maximum measured concentration of the analyte in plasma |
| Pharmacokinetics of plasma: AUClast | up to 24 hours after administration | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of plasma: AUCinf | up to 24 hours after administration | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity |
| Pharmacokinetics of plasma: Tmax | up to 24 hours after administration | Time from dosing to the maximum measured concentration of the analyte in plasma |
| Pharmacokinetics of plasma: t1/2 | up to 24 hours after administration | Terminal half-life of the analyte in plasma |
Countries
South Korea
Outcome results
None listed