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Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01609907
First received: January 5, 2012
Last updated: May 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Hyperlipidemia
Drug: Rosuvastatin+Valsartan (Sequence 1)
Drug: Rosuvastatin+Valsartan (Sequence 2)
Drug: Rosuvastatin+Valsartan (Sequence 3)
Drug: Rosuvastatin+Valsartan (Sequence 4)
Drug: Rosuvastatin+Valsartan (Sequence 5)
Drug: Rosuvastatin+Valsartan (Sequence 6)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan in Healthy Male Volunteer

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Cmax,ss of valsartan [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • AUCt,ss of valsartan [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • Cmax,ss of rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • AUCt,ss of rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • t1/2 of rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax,ss of valsartan [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • t1/2 of valsartan [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • Cmin,ss of valsartan [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • Tmax,ss of rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • Cmin,ss of rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • t1/2 of rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • Cmax,ss of N-desmetyl rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]
  • AUCt,ss of N-desmetyl rosuvastatin [ Time Frame: 18 points up to Day 4 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: Rosuvastatin+Valsartan (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 Drug: Rosuvastatin+Valsartan (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 Drug: Rosuvastatin+Valsartan (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 Drug: Rosuvastatin+Valsartan (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 Drug: Rosuvastatin+Valsartan (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 Drug: Rosuvastatin+Valsartan (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)

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609907

Locations
Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Woo-Seung Huh, MD, PhD. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01609907     History of Changes
Other Study ID Numbers: YH14700-101
Study First Received: January 5, 2012
Last Updated: May 31, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:
Drug interaction
YH14700
Rosuvastatin
Valsartan
Yuhan

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Rosuvastatin
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014