NCT04181437

Brief Summary

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2020

Shorter than P25 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

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

16 days

First QC Date

November 26, 2019

Last Update Submit

August 28, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic interaction

    Area under the curve (AUC)

    0hours - 24hours

Study Arms (3)

NVP-1203-R1

EXPERIMENTAL

Drug: NVP-1203-R1 1 tablet, oral dosing

Drug: NVP-1203-R1

NVP-1203-R2

EXPERIMENTAL

Drug: NVP-1203-R2 1 tablet, oral dosing

Drug: NVP-1203-R2

NVP-1203-R1 and NVP-1203-R2

EXPERIMENTAL

Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)

Drug: NVP-1203-R1 and NVP-1203-R2

Interventions

NVP-1203-R1DRUG

1 tablet, Single oral dosing

Also known as: NVP-1203-R1(A)
NVP-1203-R1
NVP-1203-R2DRUG

1 tablet, Single oral dosing

Also known as: NVP-1203-R2(E)
NVP-1203-R2
NVP-1203-R1 and NVP-1203-R2DRUG

NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing

Also known as: NVP-1203-R1(A) and NVP-1203-R2(E)
NVP-1203-R1 and NVP-1203-R2

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

You may not qualify if:

  • Subjects has a history of allergy reaction of study drug ingredient
  • 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)

Kyungpook National University Hospital

Daegu, Dongdeok-ro, 700-721, South Korea

Location

Study Officials

  • Yoon Y Ran, M.D.

    Kyungpook 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

November 26, 2019

First Posted

November 29, 2019

Study Start

May 1, 2020

Primary Completion

May 17, 2020

Study Completion

May 29, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)