Pharmacokinetic Interaction and Safety Between NVP-1203-R... | NCT04181437

Studies
Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2

NCT04181437

Sponsor

NVP Healthcare

Status

Completed

Last Update Posted

Sep 1, 2020Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

NVP-1203-R1
NVP-1203-R2
NVP-1203-R1 and NVP-1203-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

Aug 2020

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

May 1, 2020Actual

Primary Completion Date

May 17, 2020Actual

Completion Date

May 29, 2020Actual

First Submitted Date

Nov 26, 2019

First Submission Date that Met QC Criteria

Nov 26, 2019

First Posted Date

Nov 29, 2019Actual

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

Aug 28, 2020

Last Update Posted Date

Sep 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 and safety between NVP-1203-R1 and NVP-1203-R2

Detailed Description

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NVP-1203-R1	Drug	1 tablet, Single oral dosing	NVP-1203-R1	NVP-1203-R1(A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic interaction	Area under the curve (AUC)	0hours - 24hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy adult subjects who signed informed consent

Exclusion Criteria:

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

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
Yoon Y Ran, M.D.	Kyungpook National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital		Daegu	Dongdeok-ro	700-721	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided