Overview

DP-R213 Pharmacokinetics Study

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alvogen Korea
Treatments:
Cholecalciferol
Raloxifene Hydrochloride
Criteria
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