Trials / Completed
CompletedNCT02762643
DP-R213 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
- 61 (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
- 2016-05-01
- Primary completion
- 2016-07-01
- Completion
- 2016-08-01
- First posted
- 2016-05-05
- Last updated
- 2016-11-01
Source: ClinicalTrials.gov record NCT02762643. Inclusion in this directory is not an endorsement.