NCT04780386

Brief Summary

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2020

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

Study Start

First participant enrolled

August 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 1, 2021

Last Update Submit

March 1, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of plasma: AUClast

    0hours - 72hours

  • Pharmacokinetics of plasma: Cmax

    0hours - 72hours

Study Arms (2)

NVP-1805

EXPERIMENTAL

NVP-1805

Drug: NVP-1805

NVP-1805-R1 and NVP-1805-R2

ACTIVE COMPARATOR

coadministration of NVP-1805-R1 and NVP-1805-R2

Drug: NVP-1805-R1and NVP-1805-R2

Interventions

NVP-1805DRUG

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)

NVP-1805
NVP-1805-R1and NVP-1805-R2DRUG

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)

NVP-1805-R1 and NVP-1805-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
  • BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ 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
  • Subjects participated in another clinical trial within 6 months prior to administration of the study drug

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, M.D.

    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

March 1, 2021

First Posted

March 3, 2021

Study Start

August 29, 2020

Primary Completion

November 2, 2020

Study Completion

February 16, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

KR(1)