DP-R213 Pharmacokinetics Study

A

Alvogen

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: DP-R213
Drug: Cholecaliferol
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: Raloxifene
Drug: Cholecaliferol
Drug: DP-R213
TR group
Experimental group
Description:
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
Treatment:
Drug: Raloxifene
Drug: Cholecaliferol
Drug: DP-R213

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems