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

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ClinicalTrials.gov Identifier: NCT02160743
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Food Effect Study of CJ-30056 20mg/500mg Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CJ-30056 20mg/500mg
fasting, fed
Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)
Experimental: group 2
fed, fasting
Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)



Primary Outcome Measures :
  1. 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 ]
  2. Peak plasma concentration (Cmax) of metformin [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160743


Locations
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Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Sponsors and Collaborators
HK inno.N Corporation
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Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT02160743    
Other Study ID Numbers: CJ_ATM_104
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Metformin
Atorvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors