NCT04961905

Brief Summary

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2022

Typical duration for phase_1 healthy

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

June 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

June 29, 2021

Last Update Submit

October 3, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of plasma: Cmax

    Cmax of NVP-2002-R1 and NVP-2002-R2

    0hours - 72hours

  • Pharmacokinetics of plasma: AUCt

    Area under the curve of NVP-2002-R1 and NVP-2002-R2

    0hours - 72hours

Study Arms (4)

Single tablet fist, fasted

EXPERIMENTAL

single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition

Drug: NVP-2002-R1+NVP-2002-R2

FDC fist, fasted

EXPERIMENTAL

NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Drug: NVP-2002

Single tablet fist, fed

EXPERIMENTAL

single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition

Drug: NVP-2002-R1+NVP-2002-R2

FDC fist, fed

EXPERIMENTAL

NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Drug: NVP-2002

Interventions

NVP-2002-R1+NVP-2002-R2DRUG

NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily

Single tablet fist, fastedSingle tablet fist, fed
NVP-2002DRUG

NVP-2002 is a combination of NVP-2002-R1 and NVP-2002\_R2 NVP-2002, 1 tablet, once daily

FDC fist, fastedFDC fist, fed

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
  • Body Mass Index(BMI)=18.5\~29.9kg/㎡

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
  • Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeonbuk national university hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Officials

  • Min-Gul Kim, M.D., Ph.D

    Jeonbuk National University 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

June 29, 2021

First Posted

July 14, 2021

Study Start

September 3, 2022

Primary Completion

April 25, 2023

Study Completion

May 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

KR(1)