DP-R213 Pharmacokinetics Study | NCT02762643

Studies
DP-R213 Pharmacokinetics Study

NCT02762643

Sponsor

Alvogen Korea

Status

Completed

Last Update Posted

Nov 1, 2016Estimated

Enrollment

61Actual

Phase

Phase 1

Conditions

Healthy

Interventions

DP-R213
Raloxifene
Cholecaliferol

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

Oct 2016

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 2016

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Apr 29, 2016

First Submission Date that Met QC Criteria

May 3, 2016

First Posted Date

May 5, 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

Oct 31, 2016

Last Update Posted Date

Nov 1, 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

A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.

Detailed Description

Not provided

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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RT group	Experimental	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order	Drug: DP-R213 Drug: Raloxifene Drug: Cholecaliferol
TR group	Experimental	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order	Drug: DP-R213 Drug: Raloxifene Drug: Cholecaliferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DP-R213	Drug	Investigational product is prescribed to all of randomized subjects	RT group TR group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC)		up to 96 hours post dose
Peak Plasma Concentration (Cmax)		up to 96 hours post dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IBW ±20%
signed the informed consent form prior to the study participation

Exclusion Criteria:

Clinically significant disease
Previously donate whole blood within 2 months or component blood within 1 month
Clinically significant allergic disease
Taken IP in other trial within 3 months
An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Accepts Healthy Volunteers

Yes

Sex

Male

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

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

Intervention Browse Module

MeSH Terms

ID	Term
D020849	Raloxifene Hydrochloride

Ancestor Terms

ID	Term
D013629	Tamoxifen
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided