To Evaluate the Safety and the Pharmacokinetics of NVP-2203

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers

The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: NVP-2203; Drug: NVP-2203-R

Detailed Description

Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nambusunhwan-ro
    • Seoul, Nambusunhwan-ro, Korea, Republic of, 08779
      • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: NVP-2203; NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)
Active Comparator: 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)	Drug: NVP-2203-R; administration of active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NVP-2203's pharmacokinetics of plasma	AUCt	0hours - 72hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacokinetics of plasma	Cmax	0hours - 72hours

Collaborators and Investigators

• Sponsor: NVP Healthcare
• Investigators: Principal Investigator: Jaewoo Kim, H plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2023
• Primary Completion (Actual): June 11, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NVP-2203_BA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No