CKD-391 Pharmacokinetic Study

October 13, 2016 updated by: Chong Kun Dang Pharmaceutical

Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects

A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.

Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Study Type

Interventional

Enrollment (Actual)

52

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 Locations

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Bwt >=50kg, BMI 18~29
  • signed the informed consent form prior to the study participation

Exclusion Criteria:

  • Clinically significant disease
  • Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
  • Clinically significant allergic disease
  • Impossible to taking the institutional standard meal
  • Previously donate whole blood within 60 days or component blood within 20 days
  • Previously participated in other trial within 90 days
  • Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
  • 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: TR group
CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
Drug: CKD-391
Investigational product is prescribed to all of radomized subjects for two times.
Drug: Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.
Experimental: RT group
combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
Drug: CKD-391
Investigational product is prescribed to all of radomized subjects for two times.
Drug: Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: up to 96 hours post dose
up to 96 hours post dose
Cmax
Time Frame: up to 96 hours post dose
up to 96 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax
Time Frame: up to 96 hours post dose
up to 96 hours post dose
T1/2
Time Frame: up to 96 hours post dose
up to 96 hours post dose
AUCinf
Time Frame: up to 96 hours post dose
up to 96 hours post dose
Adverse events
Time Frame: up to 24days post dose
up to 24days post dose

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Ji Young Park, Ph.D., The Korea University Anam Hospital

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, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152BE15016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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