Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01765023

CJ_ATM_101

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Part A

Experimental group

Description:

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

Treatment:

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

Part B

Experimental group

Description:

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

Treatment:

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