DP-R213 Pharmacokinetics Study

• Sponsor: Alvogen Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02762643
• Collaborator: (none)
• Enrollment: 61
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DP-R213; Drug: Raloxifene; Drug: Cholecaliferol	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RT group combination dose of Raloxifene and Cholecaliferol and DP-R213 in order	Drug: DP-R213; Investigational product is prescribed to all of randomized subjects; Drug: Raloxifene; Investigational product is prescribed to all of randomized subjects; Drug: Cholecaliferol; Investigational product is prescribed to all of randomized subjects
Experimental: TR group combination dose of Raloxifene and Cholecaliferol and DP-R213 in order	Drug: DP-R213; Investigational product is prescribed to all of randomized subjects; Drug: Raloxifene; Investigational product is prescribed to all of randomized subjects; Drug: Cholecaliferol; Investigational product is prescribed to all of randomized subjects

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration versus time curve (AUC) [up to 96 hours post dose]

2. Peak Plasma Concentration (Cmax) [up to 96 hours post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alvogen Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alvogen Korea
• ClinicalTrials.gov Identifier: NCT02762643
• Other Study ID Numbers: DP-CTR213-I-01
• First Posted: May 5, 2016
• Last Update Posted: Nov 1, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alvogen Korea: DP-R213
• Additional relevant MeSH terms: Raloxifene Hydrochloride

Study Results

No Results Posted as of Nov 1, 2016