DP-R212 Pharmacokinetic Study Phase I

NCT ID: NCT02814500

Last Updated: 2016-06-27

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

Brief Summary

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An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

Detailed Description

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An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

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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A group

Amlodipine and Rosuvastatin, DP-R212

Group Type EXPERIMENTAL

DP-R212

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Amlodipine

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

B group

DP-R212, Amlodipine and Rosuvastatin

Group Type EXPERIMENTAL

DP-R212

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Amlodipine

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-R212

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Amlodipine

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 30 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

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Min-Geol Kim, M.D

Role: CONTACT

Other Identifiers

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DP-CTR-212-I-02

Identifier Type: -

Identifier Source: org_study_id

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