NCT05725252
Completed
Phase 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 enrollmentMay 28, 2023
Overview
- Phase
- Phase 1
- Intervention
- NVP-2203
- Conditions
- Healthy Volunteers
- Sponsor
- NVP Healthcare
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- NVP-2203's pharmacokinetics of plasma
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Eligibility Criteria
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
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
NVP-2203-R
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
Outcomes
Primary Outcomes
NVP-2203's pharmacokinetics of plasma
Time Frame: 0hours - 72hours
AUCt
Secondary Outcomes
- pharmacokinetics of plasma(0hours - 72hours)
Study Sites (1)
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