DP-R213 Phase 1 Pharmacokinetics Study
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
1 other identifier
interventional
46
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2017
CompletedStudy Start
First participant enrolled
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2017
CompletedJune 5, 2017
June 1, 2017
2 months
January 3, 2017
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the plasma concentration versus time curve (AUC)
up to 96 hours post dose
Peak Plasma Concentration (Cmax)
up to 96 hours post dose
Study Arms (2)
RT group
EXPERIMENTALcombination dose of Raloxifene and Cholecaliferol and DP-R213 in order
TR group
EXPERIMENTALcombination dose of Raloxifene and Cholecaliferol and DP-R213 in order
Interventions
Investigational product is prescribed to all of randomized subjects
Eligibility Criteria
You may qualify if:
- IBW ±20%
- Signed the informed consent form prior to the study participation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvogen Korealead
Related Publications (1)
Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15.
PMID: 36247744DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 5, 2017
Study Start
January 3, 2017
Primary Completion
March 8, 2017
Study Completion
March 29, 2017
Last Updated
June 5, 2017
Record last verified: 2017-06