Pharmacokinetic Interaction and Safety/Tolerability Betwe... | NCT03220399

Studies
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

NCT03220399

Sponsor

NVP Healthcare

Status

Withdrawn

Last Update Posted

Aug 26, 2019Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Healthy

Interventions

NVP-1603-1 (P)
NVP-1603-2 (T)
NVP-1603-1 and NVP-1603-2 (P+T)

Countries

Not provided

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 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decided to stop drug development

Expanded Access Info

Start Date

Dec 1, 2019Estimated

Primary Completion Date

Mar 28, 2020Estimated

Completion Date

Jul 31, 2020Estimated

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 18, 2017Actual

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 21, 2019

Last Update Posted Date

Aug 26, 2019Actual

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/tolerability between NVP-1603-1 and NVP-1603-2

Detailed Description

pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NVP-1603-1 (P)	Experimental	Drug: NVP-1603-1 1capsule, oral dosing	Drug: NVP-1603-1 (P)
NVP-1603-2(T)	Experimental	Drug: NVP-1603-2 1Tablet, oral dosing	Drug: NVP-1603-2 (T)
NVP-1603-1and NVP-1603-2 (P+T)	Experimental	Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)	Drug: NVP-1603-1 and NVP-1603-2 (P+T)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NVP-1603-1 (P)	Drug	1capsule, single oral dosing	NVP-1603-1 (P)	NVP-1603-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic interaction	Area under the curve (AUC)	0h - 48hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men 19years of age or older at screening test.
BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg.
Subject has signed and dated informed consent.

Exclusion Criteria:

Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
Current alcohol abuse.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Healthy males (19years of age or older)

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided