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

NCT02185066 | Completed Phase 1

• 1 other identifier: CJ_ATM_103
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference); Drug: CJ-30056 20/500mg (Test)

Group 2

EXPERIMENTAL

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

Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference); Drug: CJ-30056 20/500mg (Test)

Interventions

Atorvastatin 20mg and Metformin XR 500mg (Reference) DRUG

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.

Group 1; Group 2

CJ-30056 20/500mg (Test) DRUG

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.

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jong-lyul Ghim, MD. PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

KR (1)