DP-R213 Pharmacokinetics Study

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cholecaliferol; Drug: DP-R213; Drug: Raloxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT02762643

DP-CTR213-I-01

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

61 participants in 2 patient groups

RT group

Experimental group

Description:

combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Treatment:

Drug: Cholecaliferol

Drug: DP-R213

Drug: Raloxifene

TR group

Experimental group

Description:

combination dose of Raloxifene and Cholecaliferol and DP-R213 in order

Treatment:

Drug: Cholecaliferol

Drug: DP-R213

Drug: Raloxifene