Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

NCT01765023 | Completed Phase 1

• 1 other identifier: CJ_ATM_101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• To Evaluate PK interaction of atorvastatin and metformin

  Throughout the study

Secondary Outcomes (1)

• To Evaluate PK interaction of 2-OH-atorvastatin and metformin

  Throughout the study

Study Arms (2)

Part A

EXPERIMENTAL

single administration : atorvastatin 40mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral)

Drug: Period I : atorvastatin, Period II : atorvastatin and metformin

Part B

EXPERIMENTAL

single administration : metformin XR 1000mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral)

Drug: Period I : metformin, Period II : atorvastatin and metformin

Interventions

Period I : atorvastatin, Period II : atorvastatin and metformin DRUG

Part A

Period I : metformin, Period II : atorvastatin and metformin DRUG

Part B

Eligibility Criteria

• Age: 20 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
• Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
• 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 for this trial by investigators

You may not qualify if:

• Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
• Subjects with Symptoms of acute disease within 28days prior to study medication dosing
• Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
• Subjects with a history of abdominal surgery within food and water limit
• Subjects with a history of clinically significant allergies including drug allergies
• Subjects with anaphylaxis to atorvastatin and/or metformin
• Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
• Subjects with a history of myopathy
• Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• 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
• Creatinine clearance \<90 mL/min
• Subjects with a history of drug, caffeine and alcohol abuse(caffeine \> 5cups/day, cigarette \> 10/day, alcohol \> 30g/day) or have ever drank 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Inje University Pusan Paik Hospital

Busan, 614-735, South Korea

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 10, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

KR (1)