Trials / Completed
CompletedNCT03010267
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Alvogen Korea · Industry
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DP-R213 | Investigational product is prescribed to all of randomized subjects |
| DRUG | Raloxifene | Investigational product is prescribed to all of randomized subjects |
| DRUG | Cholecaliferol | Investigational product is prescribed to all of randomized subjects |
Timeline
- Start date
- 2017-01-03
- Primary completion
- 2017-03-08
- Completion
- 2017-03-29
- First posted
- 2017-01-05
- Last updated
- 2017-06-05
Source: ClinicalTrials.gov record NCT03010267. Inclusion in this directory is not an endorsement.