TrialReader

A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

NCT02730689 — Phase 1, Completed, 66 participants, Alvogen Korea
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone in Healthy Male Volunteers

RegistryNCT02730689
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, crossover, masking: none, basic science
Enrollment66 (Actual)
SponsorAlvogen Korea (Industry)
ConditionsHealthy Volunteers
InterventionsDP-R207, Rosuvastatin, Ezetimibe (Drug)
Datesstart 2014-12-01, primary completion 2015-01-01, completion 2015-01-01, first posted 2016-04-06, last updated 2016-04-06

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Healthy Volunteers All trials of DP-R207 All trials of Rosuvastatin

-Summary

The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered alone in health male volunteers.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
A groupExperimentalDrug: DP-R207; Drug: Rosuvastatin; Drug: EzetimibeDP-R207 >> rosuvastatin+ezetimibe
B groupActive comparatorDrug: DP-R207; Drug: Rosuvastatin; Drug: Ezetimiberosuvastatin+ezetimibe >> DP-R207
  • DP-R207 (Drug)
  • Rosuvastatin (Drug)
  • Ezetimibe (Drug)

+Outcome measures

Primary outcomes

  • Area under the plasma concentration versus time curve (AUC) [0-72hr]
  • Peak Plasma Concentration (Cmax) [0-72hr]

+Eligibility

Sex: Male, ages: 19 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy male subjects age between 19 and 55 signed informed consent

Exclusion Criteria:

* subjects have an allergy reaction of this drug

My Notes