DP-R213 Phase 1 Pharmacokinetics Study

• Status: Completed
• Trial end date: 2017-03-29
• 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