Clinical trial NCT01765023: Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
Official title: An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: To Evaluate PK interaction of atorvastatin and metformin
timeFrame: Throughout the study
Secondary outcomes:
measure: To Evaluate PK interaction of 2-OH-atorvastatin and metformin
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
Study officials:
References: