To Evaluate the Safety and the Pharmacokinetics of NVP-2203

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: NVP-2203-R; Drug: NVP-2203

• Registration Number: NCT05725252
• Lead Sponsor: NVP Healthcare

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 Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-13
• Study Start: 2023-05-28
• Primary Completion: 2023-06-11
• Study Completion: 2023-07-05
• Status Verified: 2023-10
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVP-2203-R	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)
NVP-2203	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)

Primary Outcome Measures

Name	Time	Method
NVP-2203's pharmacokinetics of plasma	0hours - 72hours	AUCt

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics of plasma	0hours - 72hours	Cmax

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Nambusunhwan-ro, Korea, Republic of