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

• Sponsor: HK inno.N Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02069821
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: combination administration	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of Exforge® (Amlodipine Besylate/Valsartan) and Lipitor® (Atorvastatin Ca) in Healthy Male Volunteers
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A single administration : amlodipine/valsartan 10/160mg, qd, 10days(oral)	Drug: combination administration; combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)
Experimental: Group B single administration : atorvastatin 40mg, qd, 7days(oral)	Drug: combination administration; combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)

Outcome Measures

Primary Outcome Measures

1. To Evaluate PK interaction of amlodipine and valsartan [from pre dosing to 24hr post dose]

   AUCss,τ, Css,max

2. To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin [from pre dosing to 24hr post dose]

   AUCss,τ, Css,max

Secondary Outcome Measures

1. To Evaluate PK interaction of amlodipine and valsartan [from pre dosing to 24hr post dose]

   tss,max, CLss/F, Css,min

2. To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin [from pre dosing to 24hr post dose]

   tss,max, CLss/F, Css,min

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam national university hospital	Daejeon	Jung-gu	Korea, Republic of	301-721

Sponsors and Collaborators

• HK inno.N Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HK inno.N Corporation
• ClinicalTrials.gov Identifier: NCT02069821
• Other Study ID Numbers: CJ_EXA_101
• First Posted: Feb 24, 2014
• Last Update Posted: Sep 12, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Sep 12, 2017