DP-R213 Phase 1 Pharmacokinetics Study

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.

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DP-R213

Drug

Investigational product is prescribed to all of randomized subjects

Raloxifene

Drug

Investigational product is prescribed to all of randomized subjects

Cholecaliferol

Drug

Investigational product is prescribed to all of randomized subjects

Primary outcomes

Area under the plasma concentration versus time curve (AUC)

Time frame: up to 96 hours post dose
Peak Plasma Concentration (Cmax)

Time frame: up to 96 hours post dose

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 5, 2017
Registry last updated: Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed