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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02730689

Enrollment

Registered

2016-04-06

Start date

2014-12-31

Completion date

2015-01-31

Last updated

2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

DP-R207, Rosuvastatin, Ezetimibe

Brief 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.

Interventions

DRUGDP-R207

DRUGRosuvastatin

DRUGEzetimibe

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* subjects have an allergy reaction of this drug

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC)	0-72hr
Peak Plasma Concentration (Cmax)	0-72hr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026