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

NCT02069821 | Completed Phase 1

• 1 other identifier: CJ_EXA_101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• To Evaluate PK interaction of amlodipine and valsartan

  AUCss,τ, Css,max

  from pre dosing to 24hr post dose

• To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin

  AUCss,τ, Css,max

  from pre dosing to 24hr post dose

Secondary Outcomes (2)

• To Evaluate PK interaction of amlodipine and valsartan

  from pre dosing to 24hr post dose

• To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin

  from pre dosing to 24hr post dose

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: combination administration

Group B

EXPERIMENTAL

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

Drug: combination administration

Interventions

combination administration DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male volunteers in the age between 20 and 45 years old
• The weight is over 55kg and is not exceed ±20% of ideal weight Ideal weight = \[height -100\]\*0.9
• Subjects with no history of any significant chronic disease
• Judged to be in good health on the basis of routine laboratory data obtained prior to study drug administration
• Willing to adhere to protocol requirements and sign a informed consent form

You may not qualify if:

• Subjects with Symptoms of acute disease within 28days prior to study medication dosing
• Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
• Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin
• Subjects with a history of myopathy
• Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• 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
• Subjects with abnormal HDL-cholesterol(\<35mg/dL)
• Subjects with abnormal of serum potassium concentration (\<3.4 mEq/L of \>5.5 mEq/L in screening visit)
• Subjects with a history of drug abuse
• Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
• 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
• Participated in a previous clinical trial within 60 days prior to dosing
• Donated blood within 60 days prior to dosing
• 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
• Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Chungnam national university hospital

Daejeon, Jung-gu, 301-721, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 24, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)