NCT04905342

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 P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2021

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

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

May 24, 2021

Last Update Submit

January 27, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of plasma: AUClast

    period 1,2,3,4

    0hours - 72hours

  • Pharmacokinetics of plasma: Cmax

    period 1,2,3,4

    0hours - 72hours

Study Arms (2)

NVP-1805

EXPERIMENTAL

NVP-1805 (80/10/20.8mg)

Drug: NVP-1805

NVP-1805-R1 and NVP-1805-R2

ACTIVE COMPARATOR

coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)

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 80/10/20.8mg)

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 80mg, NVP-1805-R2 10/20.8mg)

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
Model Details: single-dose, crossover study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

August 14, 2021

Primary Completion

December 20, 2021

Study Completion

January 7, 2022

Last Updated

February 11, 2022

Record last verified: 2022-01

Locations

KR(1)