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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185066
• Other study ID #: CJ_ATM_103
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2014
• Last updated: December 28, 2016
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2016
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Atorvastatin 20mg and Metformin XR 500mg (Reference)
Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
• CJ-30056 20/500mg (Test)
Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of Atorvastatin		Upto 36 hours	No
Primary	Maximum plasma concentration (Cmax) of Metformin		Upto 24 hours	No
Primary	Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin		Upto 36 hours	No
Primary	Area Under the plasma concentration-time Curve (AUC0-t) of Metformin		Upto 24 hours	No
Secondary	Maximum plasma concentration (Cmax) of 2-OH-atorvastatin		Upto 36 hours	No
Secondary	Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin		Upto 36 hours	No
Secondary	CL/F of Atorvastatin and Metformin		Upto 36 hours	No
Secondary	Vd/F of Atorvastatin and Metformin		Upto 36 hours	No