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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03010267
Enrollment
46
Registered
2017-01-05
Start date
2017-01-03
Completion date
2017-03-29
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

DP-R213

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.

Interventions

DRUGDP-R213

Investigational product is prescribed to all of randomized subjects

DRUGRaloxifene

Investigational product is prescribed to all of randomized subjects

DRUGCholecaliferol

Investigational product is prescribed to all of randomized subjects

Sponsors

Alvogen Korea
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026