DP-R213 Phase 1 Pharmacokinetics Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DP-R213; Drug: Raloxifene; Drug: Cholecaliferol

• Registration Number: NCT03010267
• Lead Sponsor: Alvogen Korea

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 available

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2017-03-08
• Study Completion: 2017-03-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RT group	Cholecaliferol	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
TR group	Cholecaliferol	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
RT group	DP-R213	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
TR group	DP-R213	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
RT group	Raloxifene	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
TR group	Raloxifene	combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Primary Outcome Measures

Name	Time	Method
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