DP-R212 Pharmacokinetic Study Phase I | NCT02814500

Studies
DP-R212 Pharmacokinetic Study Phase I

NCT02814500

Sponsor

Alvogen Korea

Status

Unknown status

Last Update Posted

Jun 27, 2016Estimated

Enrollment

36Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

DP-R212
Amlodipine
Rosuvastatin

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jun 12, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 27, 2016Estimated

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

Jun 23, 2016

Last Update Posted Date

Jun 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

Detailed Description

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

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

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A group	Experimental	Amlodipine and Rosuvastatin, DP-R212	Drug: DP-R212 Drug: Amlodipine Drug: Rosuvastatin
B group	Experimental	DP-R212, Amlodipine and Rosuvastatin	Drug: DP-R212 Drug: Amlodipine Drug: Rosuvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DP-R212	Drug	Investigational product is prescribed to all of randomized subjects	A group B group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUClast		0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
Cmax		0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 17.5~30.5
signed the informed consent form prior to the study participation

Exclusion Criteria:

Clinically significant disease
Previously donate whole blood within 60 days or component blood within 30 days
Clinically significant allergic disease
Taken IP in other trial within 90 days
An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Min-Geol Kim, M.D	Contact			mgkim@jbcp.kr

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

Intervention Browse Module

MeSH Terms

ID	Term
D017311	Amlodipine
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided