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

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DP-R207; Drug: Rosuvastatin; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT02730689

DP-CTR207-I-03

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

A group

Experimental group

Description:

DP-R207 \>\> rosuvastatin+ezetimibe

Treatment:

Drug: Ezetimibe

Drug: Rosuvastatin

Drug: DP-R207

B group

Active Comparator group

Description:

rosuvastatin+ezetimibe \>\> DP-R207

Treatment:

Drug: Ezetimibe

Drug: Rosuvastatin

Drug: DP-R207