Clinical Trial to Compare the Pharmacokinetics of DP-R208

Alvogen Korea40 enrolled

Overview

A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DP-R208DRUG

Investigational product is prescribed to all of randomized subjects

Candesartan cilexetilDRUG

Investigational product is prescribed to all of randomized subjects

RosuvastatinDRUG

Investigational product is prescribed to all of randomized subjects

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 17.5\~30.5 * signed the informed consent form prior to the study participation Exclusion Criteria: * Clinically significant disease * Previously donate whole blood within 60 days or component blood within 14 days * Clinically significant allergic disease * Taken IP in other trial within 90 days * An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Time frame: up to 72 hours post dose

Area under the plasma concentration versus time curve (AUC)

Time frame: up to 72 hours post dose

Data from ClinicalTrials.gov

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