NVP-1805 Compared to Coadministration of NVP-1805-R1 With... | NCT04905342

Studies
NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

NCT04905342

Sponsor

NVP Healthcare

Status

Completed

Last Update Posted

Feb 11, 2022Actual

Enrollment

58Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

NVP-1805
NVP-1805-R1and NVP-1805-R2

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2021Actual

Primary Completion Date

Dec 20, 2021Actual

Completion Date

Jan 7, 2022Actual

First Submitted Date

May 24, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2022

Last Update Posted Date

Feb 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NVP-1805	Drug	orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)	NVP-1805

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of plasma: AUClast	period 1,2,3,4	0hours - 72hours
Pharmacokinetics of plasma: Cmax	period 1,2,3,4	0hours - 72hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaewoo Kim, M.D.	H Plus Yangji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H Plus Yangji Hospital		Seoul	Nambusunhwan-ro	08779	South Korea