Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Period I : atorvastatin, Period II : atorvastatin and metformin; Drug: Period I : metformin, Period II : atorvastatin and metformin

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 614-735
    • Inje University Pusan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Willing to adhere to protocol requirements and sign a informed consent form
2. 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
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 for this trial by investigators

Exclusion Criteria:

1. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
2. Subjects with Symptoms of acute disease within 28days prior to study medication dosing
3. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
4. Subjects with a history of abdominal surgery within food and water limit
5. Subjects with a history of clinically significant allergies including drug allergies
6. Subjects with anaphylaxis to atorvastatin and/or metformin
7. Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
8. Subjects with a history of myopathy
9. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

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
    • Creatinine clearance <90 mL/min
11. 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
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. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration
16. Subjects considered as unsuitable based on medical judgement by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; 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
Experimental: Part B; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Evaluate PK interaction of atorvastatin and metformin	Throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
To Evaluate PK interaction of 2-OH-atorvastatin and metformin	Throughout the study

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 7, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Metformin
• Other Study ID Numbers: CJ_ATM_101