DP-R212 Pharmacokinetic Study Phase I

June 23, 2016 updated by: Alvogen Korea

DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group
Amlodipine and Rosuvastatin, DP-R212
Drug: Rosuvastatin
Investigational product is prescribed to all of randomized subjects
Drug: DP-R212
Investigational product is prescribed to all of randomized subjects
Drug: Amlodipine
Investigational product is prescribed to all of randomized subjects
Experimental: B group
DP-R212, Amlodipine and Rosuvastatin
Drug: Rosuvastatin
Investigational product is prescribed to all of randomized subjects
Drug: DP-R212
Investigational product is prescribed to all of randomized subjects
Drug: Amlodipine
Investigational product is prescribed to all of randomized subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
Cmax
Time Frame: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 12, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR-212-I-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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