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NCT02730689 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02730689
Other study ID # DP-CTR207-I-03
Secondary ID
Status Completed
Phase Phase 1
First received March 16, 2016
Last updated April 1, 2016
Start date December 2014
Est. completion date January 2015

Study information
Verified date May 2015
Source Alvogen Korea
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- subjects have an allergy reaction of this drug

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• DP-R207

• Rosuvastatin

• Ezetimibe

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alvogen Korea

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve (AUC) 0-72hr No
Primary Peak Plasma Concentration (Cmax) 0-72hr No
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