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
| Registry | NCT03010267 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 46 (Actual) |
| Sponsor | Alvogen Korea (Industry) |
| Conditions | Healthy |
| Interventions | DP-R213, Raloxifene, Cholecaliferol (Drug) |
| Dates | start 2017-01-03, primary completion 2017-03-08, completion 2017-03-29, first posted 2017-01-05, last updated 2017-06-05 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| RT group | Experimental | Drug: DP-R213; Drug: Raloxifene; Drug: Cholecaliferol | combination dose of Raloxifene and Cholecaliferol and DP-R213 in order |
| TR group | Experimental | Drug: DP-R213; Drug: Raloxifene; Drug: Cholecaliferol | combination dose of Raloxifene and Cholecaliferol and DP-R213 in order |
Sex: Male, ages: 19 Years to any, 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