Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor 20mg/Glucophage SR 750mg

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Atorvastatin 20mg and Metformin SR 750mg; Drug: CJ-30056 20/750mg

• Registration Number: NCT02378441
• Lead Sponsor: HK inno.N Corporation

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 20mg and metformin SR 750mg, in healthy volunteers.

Detailed Description

To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-16
• Primary Completion: 2015-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Study Completion: 2015-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

1. Willing to adhere to protocol requirements and sign a informed consent form
2. Male volunteers in the age between 19 and 55 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 28 days before dosing

2. Symptom of an acute illness within 28 days 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. Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.)

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
    • e-GFR <90 mL/min

11. History of drug, caffein(caffein > 400mg/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

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. Use of any other medication, including herbal products, within 10 days before dosing

16. Subjects considered as unsuitable based on medical judgement by investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Atorvastatin 20mg and Metformin SR 750mg	Atorvastatin 20mg and Metformin SR 750mg	co-administration of Atorvastatin 20mg and Metformin SR 750mg
CJ-30056 20/750mg	Atorvastatin 20mg and Metformin SR 750mg	fixed-dose combination of Atorvastatin 20mg and Metformin SR 750mg
CJ-30056 20/750mg	CJ-30056 20/750mg	fixed-dose combination of Atorvastatin 20mg and Metformin SR 750mg
Atorvastatin 20mg and Metformin SR 750mg	CJ-30056 20/750mg	co-administration of Atorvastatin 20mg and Metformin SR 750mg

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of Atorvastatin and Metformin	Up to 32 hours

Secondary Outcome Measures

Name	Time	Method
Area under the curve(AUC) of Atorvastatin and Metformin	Up to 32 hours