Clinical Trial to Compare the Pharmacokinetics of DP-R208

NCT ID: NCT02707224

Last Updated: 2016-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order

Group Type EXPERIMENTAL

DP-R208

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Candesartan cilexetil

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Rosuvastatin

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Group B

DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order

Group Type EXPERIMENTAL

DP-R208

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Candesartan cilexetil

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Rosuvastatin

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Interventions

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DP-R208

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Candesartan cilexetil

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Rosuvastatin

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min-Gul Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Other Identifiers

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DP-CTR208-I-02

Identifier Type: -

Identifier Source: org_study_id

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