NCT05725252CompletedPhase 1
Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers
NVP Healthcare1 site in 1 country50 target enrollmentStarted: May 28, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- NVP-2203's pharmacokinetics of plasma
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.
Detailed Description
Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adult subjects who signed informed consent
- •BMI of >18.0 kg/m2 and <30.0 kg/m2 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
Arms & Interventions
NVP-2203
Experimental
After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)
Intervention: NVP-2203 (Drug)
NVP-2203-R
Active Comparator
After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)
Intervention: NVP-2203-R (Drug)
Outcomes
Primary Outcomes
NVP-2203's pharmacokinetics of plasma
Time Frame: 0hours - 72hours
AUCt
Secondary Outcomes
- pharmacokinetics of plasma(0hours - 72hours)
Investigators
Study Sites (1)
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