Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

December 28, 2016 updated by: HK inno.N Corporation
This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Willing to adhere to protocol requirements and sign a informed consent form
  2. Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
  3. Subjects with no history of any significant chronic disease
  4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criteria:

  1. Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
  2. Symptom of an acute illness within 4 weeks prior to drug administration
  3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
  4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
  5. History of clinically significant allergies including drug allergies
  6. History of clinically significant allergies about atorvastatin or metformin
  7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
  8. History of myopathy

  9. Clinical laboratory test values are outside the accepted normal range

    • AST or ALT >1.25 times to normal range
    • Total bilirubin >1.5 times to normal range
    • e-GFR <90 mL/min
  10. History of drug, caffein(caffein > 5 cups/day), smoking (cigarette > 10/day) or alcohol abuse(alcohol > 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
  11. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
  12. Donated blood within 60 days prior to dosing
  13. Participated in a previous clinical trial within 60 days prior to dosing
  14. Use of any other medication, including herbal products, within 10 days before dosing
  15. Subjects considered as unsuitable based on medical judgement by investigators

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1

Single-dose crossover

  1. Reference: Atorvastatin 20mg and Metformin XR 500mg
  2. Test: CJ-30056 20/500mg

Once daily Oral administration with 7days of washout period
Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Drug: CJ-30056 20/500mg (Test)

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
Experimental: Group 2

Single-dose crossover

  1. Test: CJ-30056 20/500mg
  2. Reference: Atorvastatin 20mg and Metformin XR 500mg

Once daily Oral administration with 7days of washout period
Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Drug: CJ-30056 20/500mg (Test)

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax) of Atorvastatin
Time Frame: Upto 36 hours
Upto 36 hours
Maximum plasma concentration (Cmax) of Metformin
Time Frame: Upto 24 hours
Upto 24 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin
Time Frame: Upto 36 hours
Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Metformin
Time Frame: Upto 24 hours
Upto 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax) of 2-OH-atorvastatin
Time Frame: Upto 36 hours
Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin
Time Frame: Upto 36 hours
Upto 36 hours
CL/F of Atorvastatin and Metformin
Time Frame: Upto 36 hours
Upto 36 hours
Vd/F of Atorvastatin and Metformin
Time Frame: Upto 36 hours
Upto 36 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HK inno.N Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jong-lyul Ghim, MD. PhD, Inje University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CJ_ATM_103

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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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