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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: combination administration

• Registration Number: NCT02069821
• Lead Sponsor: HK inno.N Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Study Start: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	combination administration	single administration : amlodipine/valsartan 10/160mg, qd, 10days(oral)
Group B	combination administration	single administration : atorvastatin 40mg, qd, 7days(oral)

Primary Outcome Measures

Name	Time	Method
To Evaluate PK interaction of amlodipine and valsartan	from pre dosing to 24hr post dose	AUCss,τ, Css,max
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin	from pre dosing to 24hr post dose	AUCss,τ, Css,max

Secondary Outcome Measures

Name	Time	Method
To Evaluate PK interaction of amlodipine and valsartan	from pre dosing to 24hr post dose	tss,max, CLss/F, Css,min
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin	from pre dosing to 24hr post dose	tss,max, CLss/F, Css,min

Trial Locations

Locations (1)

Chungnam national university hospital; 🇰🇷 Daejeon, Jung-gu, Korea, Republic of