Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
Overview[ - collapse ][ - ]
Purpose | The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers |
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Condition | Healthy |
Intervention | Drug: Period I : atorvastatin, Period II : atorvastatin and metformin Drug: Period I : metformin, Period II : atorvastatin and metformin |
Phase | Phase 1 |
Sponsor | CJ Cheiljedang Corporation |
Responsible Party | CJ Cheiljedang Corporation |
ClinicalTrials.gov Identifier | NCT01765023 |
First Received | December 12, 2012 |
Last Updated | April 7, 2013 |
Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | December 12, 2012 |
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Last Updated Date | April 7, 2013 |
Start Date | October 2012 |
Estimated Primary Completion Date | January 2013 |
Current Primary Outcome Measures | To Evaluate PK interaction of atorvastatin and metformin [Time Frame: Throughout the study] [Designated as safety issue: No] |
Current Secondary Outcome Measures | To Evaluate PK interaction of 2-OH-atorvastatin and metformin [Time Frame: Throughout the study] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects |
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Official Title | An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects |
Brief Summary | The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science |
Condition | Healthy |
Intervention | Drug: Period I : atorvastatin, Period II : atorvastatin and metformin Drug: Period I : metformin, Period II : atorvastatin and metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 80 |
Estimated Completion Date | January 2013 |
Estimated Primary Completion Date | December 2012 |
Eligibility Criteria | Inclusion Criteria: 1. Willing to adhere to protocol requirements and sign a informed consent form 2. Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9 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 for this trial by investigators Exclusion Criteria: 1. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing 2. Subjects with Symptoms of acute disease within 28days prior to study medication dosing 3. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines 4. Subjects with a history of abdominal surgery within food and water limit 5. Subjects with a history of clinically significant allergies including drug allergies 6. Subjects with anaphylaxis to atorvastatin and/or metformin 7. Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration 8. Subjects with a history of myopathy 9. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 10. 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 - Creatinine clearance <90 mL/min 11. Subjects with a history of drug, caffeine and alcohol abuse(caffeine > 5cups/day, cigarette > 10/day, alcohol > 30g/day) or have ever drank within 7 days prior to drug administration 12. 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 13. Donated blood within 60 days prior to dosing 14. Participated in a previous clinical trial within 60 days prior to dosing 15. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration 16. Subjects considered as unsuitable based on medical judgement by investigators |
Gender | Male |
Ages | 20 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01765023 |
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Other Study ID Numbers | CJ_ATM_101 |
Has Data Monitoring Committee | No |
Information Provided By | CJ Cheiljedang Corporation |
Study Sponsor | CJ Cheiljedang Corporation |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | April 2013 |
Locations[ + expand ][ + ]
Inje University Pusan Paik Hospital | Busan, Korea, Republic of, 614-735 |
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