NCT02762643

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

April 29, 2016

Last Update Submit

October 31, 2016

Conditions

Healthy

Keywords

DP-R213

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

RT group

EXPERIMENTAL

combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Drug: DP-R213Drug: RaloxifeneDrug: Cholecaliferol

TR group

EXPERIMENTAL

combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Drug: DP-R213Drug: RaloxifeneDrug: Cholecaliferol

Interventions

DP-R213DRUG

Investigational product is prescribed to all of randomized subjects

RT groupTR group
RaloxifeneDRUG

Investigational product is prescribed to all of randomized subjects

RT groupTR group
CholecaliferolDRUG

Investigational product is prescribed to all of randomized subjects

RT groupTR group

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Raloxifene Hydrochloride

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share