Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects

NCT ID: NCT02069821

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

Brief Summary

The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group A

single administration : amlodipine/valsartan 10/160mg, qd, 10days(oral)

Group Type: EXPERIMENTAL

combination administration

Intervention Type: DRUG

combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)

Group B

single administration : atorvastatin 40mg, qd, 7days(oral)

Group Type: EXPERIMENTAL

combination administration

Intervention Type: DRUG

combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)

Interventions

combination administration

combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male volunteers in the age between 20 and 45 years old

2. The weight is over 55kg and 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 routine laboratory data obtained prior to study drug administration

5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria

1. Subjects with Symptoms of acute disease within 28days prior to study medication dosing

2. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines

3. Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin

4. Subjects with a history of myopathy

5. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

6. Subject with the mean blood pressure of siDBP ≥ 150 mmHg or ≤ 90 mmHg and/or siSBP ≥ 95 mmHg or ≤ 50 mmHg at the screening visit

7. Subjects with abnormal HDL-cholesterol(<35mg/dL)

8. Subjects with abnormal of serum potassium concentration (<3.4 mEq/L of >5.5 mEq/L in screening visit)

9. Subjects with a history of drug abuse

10. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing

11. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 14days prior to drug administration and OTC or vitamin within 7days prior to drug administration

12. Participated in a previous clinical trial within 60 days prior to dosing

13. Donated blood within 60 days prior to dosing

14. Subjects with a history of alcohol abuse(over 21 units/week, 1 unit = 10 g of pure alcohol) or is difficult to stop drinking within study

15. Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration

16. Subjects with a history of caffeine abuse or or is difficult to stop drinking within study

17. Subjects with biliary obstruction

18. Subjects with hepatic dysfunction (AST or ALT >3 times to accepted normal range)

19. Subjects with moderate renal dysfunction (creatinine clearance (CLcr) < 30mL/min)

20. Subjects considered as unsuitable based on medical judgement by investigators

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungnam national university hospital

Daejeon, Jung-gu, South Korea

Countries

South Korea

Other Identifiers

CJ_EXA_101

Identifier Type: -

Identifier Source: org_study_id