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Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg

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ClinicalTrials.gov Identifier: NCT01918358
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Study Description
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Brief Summary:
To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab 160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and Crestor® (Rosuvastatin) 20 mg in healthy male volunteers

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R) Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1) Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1) Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ) Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ) Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose Crossover Study to Compare the Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg in Healthy Male Volunteers
Study Start Date : December 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fixed-dose combination VR 160/20 mg-1
Fixed-dose combination VR 160/20 mg-1 is administered by mouth at Day 1, 8 and 15.
 Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 )
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor
Experimental: Fixed-dose combination VR 160/20 mg-2
Fixed-dose combination VR 160/20 mg-2 is administered by mouth at Day 1, 8 and 15.
 Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 )
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor
Experimental: Valsartan 160mg placebo + Rosuvastatin 20mg
Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered by mouth at Day 1, 8 and 15.
 Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 )
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor

Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)
Other Names:
  • Rovatitan tab
  • Diovan
  • Crestor


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of valsartan and rosuvastatin [ Time Frame: 0h(pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 12h, 24h, 48h for each period (total 16 times) ]
  2. AUC last of valsartan and rosuvastatin [ Time Frame: 0h(pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 12h, 24h, 48h for each period (total 16 times) ]

Other Outcome Measures:
  1. Safety evaluation [ Time Frame: -28~-2d, 1d, 2d, 3d, 8d, 9d, 10d, 15d, 16d, 17d, 21 ± 2d ]
    The severity of adverse events and their relationship with the investigational products are schematized by treatment group. Descriptive statistics are calculated for the frequency, percentage, 12-lead ECG and clinical laboratory tests results of the subjects who have adverse events and the results of each item are reviewed.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male aged 20~45 years at screening
  2. 19 kg/m2 ≤ BMI ≤27 kg/m2 at screening
  3. Subject who is able to communicate with investigators and understand the nature of the clinical study and is willing and able to provide a written informed consent form

Exclusion Criteria:

  1. Subject with current or previous clinically significant diseases in liver, renal, neurologic, pulmonary, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, psychological, and musculoskeletal system
  2. Patient with renal defects (Calculated GFR < 60 ml/min based on serum creatinine level )
  3. Subject who can not satisfy the following criteria for sitting blood pressure at screening test 90 ≤SBP <140 (mmHg) 60 ≤ DBP <90 (mmHg)
  4. Subject who can not satisfy the following criteria at screening 1) AST and ALT ≤ 1.5x ULN 2) Serum total bilirubin ≤ 1.5x ULN 3) CK (Creatinine kinase) ≤ 2x ULN
  5. Subject with a medical history of gastrointestinal diseases (e.g., Crohn's disease, ulcer) or a surgery (for appendicitis and hernia repair are allowed) that might affect the investigational product absorption
  6. Subject with hypersensitivity to the drugs containing components of valsartan and rosuvastatin or other drugs (aspirin, antibiotics) or a previous clinically significant history of hypersensitivity
  7. Subject with a previous history of drug overdose or a positive to the drugs (Barbiturate, Benzodiazepine, Methamphetamine, Cannabinoids, Cocaine, Opiate) in urine drug screening test
  8. Subject who has taken any prescribed medicines or oriental medicines within two weeks before the first investigational product administration, or who has taken any over-the-counter drugs within one week before the first investigational product administration (If the subject is eligible for all other criteria, he or she may participate in the clinical study based on investigator's discretion.)
  9. Subject who has taken other investigational products within 60 days before the first investigational product administration
  10. Subject who donated whole blood within 60 days or donated apheresis blood within 30 days or received a transfusion within 30 days before the first investigational product administaration.
  11. Subject who has taken the drugs that induce or inhibit drug-metabolizing enzymes such as barbiturates within 30 days before the first investigational product administration
  12. Subject with a daily intake of drinks containing caffeine (coffee, tea, coke) or grapefruit juice > average of 4 cups / day (800 mL) or a subject who can not discontinue such drinks during the clinical study period(from screening to post-study visit)
  13. Subject with a mean weekly drinking amount of > 140g or a subject who can not stop drinking until outpatient visit after the investigational product administration, including the hospitalization in each period.
  14. Subject with a mean daily smoking amount of > 10 cigarettes or a subject who can not stop smoking during the hospitalization
  15. Subject positive result in serology tests (hepatitis B, hepatitis C, HIV)
  16. Subject with genetic muscle disease, or familial history of muscle disease, or medical history of drug-derived muscle disorder
  17. Subject who is considered not to be eligible at investigator's discretion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918358


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
More Information
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01918358    
Other Study ID Numbers: LG-VRCL005
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists