NCT05725252

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 28, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

January 11, 2024

Status Verified

October 1, 2023

Enrollment Period

14 days

First QC Date

January 24, 2023

Last Update Submit

January 9, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • NVP-2203's pharmacokinetics of plasma

    AUCt

    0hours - 72hours

Secondary Outcomes (1)

  • pharmacokinetics of plasma

    0hours - 72hours

Study Arms (2)

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)

Drug: NVP-2203

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)

Drug: NVP-2203-R

Interventions

NVP-2203DRUG

NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)

NVP-2203
NVP-2203-RDRUG

administration of active comparator

NVP-2203-R

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospital

Seoul, Nambusunhwan-ro, 08779, South Korea

Location

Study Officials

  • Jaewoo Kim

    H Plus Yangji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 13, 2023

Study Start

May 28, 2023

Primary Completion

June 11, 2023

Study Completion

July 5, 2023

Last Updated

January 11, 2024

Record last verified: 2023-10

Locations

KR(1)