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

Alvogen Korea0 sites46 target enrollmentStarted: January 3, 2017Last updated: June 5, 2017

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 46
Primary Endpoint: Area under the plasma concentration versus time curve (AUC)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 19 Years to — (Adult, Older Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•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