Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01765023
First received: December 12, 2012
Last updated: April 7, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Period I : atorvastatin, Period II : atorvastatin and metformin
Drug: Period I : metformin, Period II : atorvastatin and metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by CJ Cheiljedang Corporation:

Primary Outcome Measures:
  • To Evaluate PK interaction of atorvastatin and metformin [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Evaluate PK interaction of 2-OH-atorvastatin and metformin [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765023

Locations
Korea, Republic of
Inje University Pusan Paik Hospital
Busan, Korea, Republic of, 614-735
Sponsors and Collaborators
CJ Cheiljedang Corporation
  More Information

No publications provided

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01765023     History of Changes
Other Study ID Numbers: CJ_ATM_101
Study First Received: December 12, 2012
Last Updated: April 7, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Additional relevant MeSH terms:
Metformin
Atorvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014