Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference); Drug: CJ-30056 20/500mg (Test)

• Registration Number: NCT02185066
• 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 and metformin XR, in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-09
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

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 4 weeks before dosing

2. Symptom of an acute illness within 4 weeks 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. 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

10. 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

11. 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

12. Donated blood within 60 days prior to dosing

13. Participated in a previous clinical trial within 60 days prior to dosing

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Atorvastatin 20mg and Metformin XR 500mg (Reference)	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
Group 1	CJ-30056 20/500mg (Test)	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
Group 2	CJ-30056 20/500mg (Test)	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
Group 2	Atorvastatin 20mg and Metformin XR 500mg (Reference)	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

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of Atorvastatin	Upto 36 hours
Maximum plasma concentration (Cmax) of Metformin	Upto 24 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin	Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Metformin	Upto 24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of