NCT05023031

Brief Summary

The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_1

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

July 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

July 5, 2021

Last Update Submit

January 17, 2022

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Evaluation of Area under the plasma drug concentration-time curve(AUCt)

    Pharmacokinetics parameter derived from plasma

    0 ~ 72 hours

  • Evaluation of Maximum observed plasma concentration(Cmax)

    Pharmacokinetics parameter derived from plasma

    0 ~ 72 hours

Secondary Outcomes (6)

  • Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)

    0 ~ 72 hours

  • Evaluation of AUCt/AUC∞

    0 ~ 72 hours

  • Evaluation of Time of peak concentration(Tmax)

    0 ~ 72 hours

  • Evaluation of Terminal phase of Half-life(t1/2)

    0 ~ 72 hours

  • Evaluation of total clearance of the drug from plasma after oral administration(CL/F)

    0 ~ 72 hours

  • +1 more secondary outcomes

Study Arms (2)

NVP-2102

EXPERIMENTAL

NVP-2102

Drug: NVP-2102

NVP-2102-R

ACTIVE COMPARATOR

NVP-2102-R

Drug: NVP-2102-R

Interventions

NVP-2102DRUG

Tablet formulation for oral administration, single dose of NVP-2102 at Day 1

NVP-2102
NVP-2102-RDRUG

Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1

NVP-2102-R

Eligibility Criteria

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

You may qualify if:

  • Healthy subject, 19 years of age or older
  • Subjects who signed informed consent
  • Body mass index(BMI) of 18 to 30.0 kg/㎡

You may not qualify if:

  • Subject who has clinically significant medical history
  • Inadequate subject for the clinical trial by the investigator's decision
  • Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

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

  • Jae Woo Kim

    H+ 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

July 5, 2021

First Posted

August 26, 2021

Study Start

October 5, 2021

Primary Completion

December 24, 2021

Study Completion

January 15, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)