Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
Overview
- Phase
- Phase 1
- Intervention
- Atorvastatin 20mg and Metformin XR 500mg (Reference)
- Conditions
- Healthy Volunteers
- Sponsor
- HK inno.N Corporation
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration (Cmax) of Atorvastatin
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 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
Arms & Interventions
Group 1
Single-dose crossover 1. Reference: Atorvastatin 20mg and Metformin XR 500mg 2. Test: CJ-30056 20/500mg Once daily Oral administration with 7days of washout period
Intervention: Atorvastatin 20mg and Metformin XR 500mg (Reference)
Group 1
Single-dose crossover 1. Reference: Atorvastatin 20mg and Metformin XR 500mg 2. Test: CJ-30056 20/500mg Once daily Oral administration with 7days of washout period
Intervention: CJ-30056 20/500mg (Test)
Group 2
Single-dose crossover 1. Test: CJ-30056 20/500mg 2. Reference: Atorvastatin 20mg and Metformin XR 500mg Once daily Oral administration with 7days of washout period
Intervention: Atorvastatin 20mg and Metformin XR 500mg (Reference)
Group 2
Single-dose crossover 1. Test: CJ-30056 20/500mg 2. Reference: Atorvastatin 20mg and Metformin XR 500mg Once daily Oral administration with 7days of washout period
Intervention: CJ-30056 20/500mg (Test)
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax) of Atorvastatin
Time Frame: Upto 36 hours
Maximum plasma concentration (Cmax) of Metformin
Time Frame: Upto 24 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin
Time Frame: Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Metformin
Time Frame: Upto 24 hours
Secondary Outcomes
- Maximum plasma concentration (Cmax) of 2-OH-atorvastatin(Upto 36 hours)
- Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin(Upto 36 hours)
- CL/F of Atorvastatin and Metformin(Upto 36 hours)
- Vd/F of Atorvastatin and Metformin(Upto 36 hours)