Status:
COMPLETED
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy Volunteers
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
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 vo...
Eligibility Criteria
Inclusion
- Willing to adhere to protocol requirements and sign a informed consent form
- Male volunteers in the age between 19 and 55 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02185066
Start Date
July 1 2014
End Date
November 1 2014
Last Update
December 29 2016
Active Locations (1)
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1
Inje University Busan Paik Hospital
Busan, South Korea