DP-R213 Pharmacokinetics Study
- Registration Number
- NCT02762643
- Lead Sponsor
- Alvogen Korea
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 61
Inclusion Criteria
- IBW ±20%
- signed the informed consent form prior to the study participation
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description RT group Cholecaliferol combination dose of Raloxifene and Cholecaliferol and DP-R213 in order TR group Cholecaliferol combination dose of Raloxifene and Cholecaliferol and DP-R213 in order RT group DP-R213 combination dose of Raloxifene and Cholecaliferol and DP-R213 in order TR group DP-R213 combination dose of Raloxifene and Cholecaliferol and DP-R213 in order RT group Raloxifene combination dose of Raloxifene and Cholecaliferol and DP-R213 in order TR group Raloxifene combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method