- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160743
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
Status
Completed
Conditions
Intervention / Treatment
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
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Busan, Korea, Republic of, 614-735
- Inje University Busan Paik Hospital
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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:
- Willing to adhere to protocol requirements and sign a informed consent form
- Male volunteers in the age between 20 and 45 years old and have the weight range is not exceed ±20% of ideal weight
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
Exclusion Criteria:
- Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
- Symptom of an acute illness within 4 weeks prior to drug administration
- History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
- History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
- History of clinically significant allergies including drug allergies
- History of clinically significant allergies about atorvastatin or metformin
- 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
- History of myopathy
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
- 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
- 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
- Donated blood within 60 days prior to dosing
- Participated in a previous clinical trial within 60 days prior to dosing
- Use of any other medication, including herbal products, within 10 days before dosing
- 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
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Experimental: group 2
fed, fasting
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CJ_ATM_104
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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