The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects

December 28, 2016 updated by: HK inno.N Corporation
This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of "CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)" in healthy male subjects

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

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

      • Busan, Korea, Republic of, 614-735
        • Inje University Busan Paik Hospital

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

Male

Description

Inclusion Criteria:

  1. Willing to adhere to protocol requirements and sign a informed consent form
  2. Male volunteers in the age between 20 and 45 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
Intervention / Treatment
Experimental: CJ-30056 20mg/500mg
fasting, fed
Experimental: group 2
fed, fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration (Cmax) of atorvastatin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
Peak plasma concentration (Cmax) of metformin
Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
area under the plasma concentration versus time curve (AUC0-t) of atorvastatin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
area under the plasma concentration versus time curve (AUC0-t) of metformin
Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration (Cmax) of 2-OH-atorvastatin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
Vz/F of atorvastatin and metformin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
area under the plasma concentration versus time curve (AUC0-t) of 2-OH-atorvastatin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
AUCinf of Atorvastatin, 2-OH-atorvastatin and metformin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
Tmax of Atorvastatin, 2-OH-atorvastatin and metformin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
t1/2β of Atorvastatin, 2-OH-atorvastatin and metformin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
CL/F of atorvastatin and metformin
Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose

Collaborators and Investigators

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

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

May 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

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.

Clinical Trials on CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)

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