Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan

May 31, 2012 updated by: Yuhan Corporation

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan in Healthy Male Volunteer

The objective of this study is to compare pharmacokinetics after single oral administration of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and valsartan in healthy male volunteers.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers of aged between 20 years to 50 years
  • Have a body mass index (BMI) between 19kg/m2 and 27kg/m2 inclusive
  • Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period
  • Able to follow instruction and can participate in whole procedure of the trial
  • Have signed a written informed consent voluntary, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the drug
  • Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study

Exclusion Criteria:

  • Have history of cardiovascular disorder(congestive heart failure, complications of coronary artery stenosis stroke and etc.), respiratory disorder, renal disorder(severe renal failure and etc.), liver disorder(moderate or severe liver failure and etc.) endocrine system disorder(diabetics, impaired glucose tolerance and etc.), digestive system disorder, central nervous system disorder, mental illness or malignant tumor
  • Have history of gastrointestinal disease(Crohn's disease, ulcer and etc.), gastrointestinal surgery(simple appendectomy or herniotomy excluded) that can affect the absorption of the drug
  • Have suffered from a clinically significant disease within 30 days prior to the first administration
  • Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with rosuvastatin or valsartan, or other drug(aspirin, antibiotics and etc.)
  • Have genetic myopathy, family history of myopathy, or history of myopathy to drugs
  • Have systolic blood pressure higher than 150mmHg or lower than 90mmHg, or diastolic blood pressure higher than 100mmHg or lower than 60mmHg, or pulse rate more than 100times/min or less than 40times/min
  • Have history of drug abuse or shown positive on drug abuse during drug screening test
  • Participated in any other clinical trials within 90 days prior to the first administration
  • Have used any herbal medicine, prescription drug, or generic medicine within 30 days, 14 days or 7 days prior to the first administration, respectively (provided, however, if other conditions are judged to be eligible by investigators, subjects can participate in the trial)
  • Donated whole blood or blood component within 60 days or 30 days prior to the first administration, respectively, or received transfusion within 30 days prior to the first administration
  • Excessive alcohol drinker(> 140g/week; 1 glass of 12° wine(125mL) = 12.0g, 1 glass of 4° beer(250mL) = 8g, 0.5 bottle of soju(180mL) = 28.8g)
  • Heavy smoker(> 20 cigarettes/day)
  • Excessive caffeine drinker(> 4 cups/day)
  • Shown positive on serum test(HBsAg, HCV Ab, HIV Ab tests)
  • Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal values in clinical laboratory test
  • Continuous increase of liver enzyme level(AST, ALT) of unknown cause or active liver disorder patients with liver enzyme level increasing more than 3 time of normal upper limit
  • Severe renal disorder patients(with creatinine clearance (Cr) < 10mL/min when calculated with Modification of Diet in Renal Disease method)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence 1
Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
EXPERIMENTAL: Sequence 2
Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
EXPERIMENTAL: Sequence 3
Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
EXPERIMENTAL: Sequence 4
Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
EXPERIMENTAL: Sequence 5
Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
EXPERIMENTAL: Sequence 6
Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax,ss of valsartan
Time Frame: 18 points up to Day 4
18 points up to Day 4
AUCt,ss of valsartan
Time Frame: 18 points up to Day 4
18 points up to Day 4
Cmax,ss of rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4
AUCt,ss of rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4
t1/2 of rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4

Secondary Outcome Measures

Outcome Measure
Time Frame
t1/2 of rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4
Tmax,ss of valsartan
Time Frame: 18 points up to Day 4
18 points up to Day 4
t1/2 of valsartan
Time Frame: 18 points up to Day 4
18 points up to Day 4
Cmin,ss of valsartan
Time Frame: 18 points up to Day 4
18 points up to Day 4
Tmax,ss of rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4
Cmin,ss of rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4
Cmax,ss of N-desmetyl rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4
AUCt,ss of N-desmetyl rosuvastatin
Time Frame: 18 points up to Day 4
18 points up to Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Woo-Seung Huh, MD, PhD., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (ESTIMATE)

June 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

January 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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