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Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01918709
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Brief Summary:

Primary objective : To investigate pharmacokinetics after concomitant administration of valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in healthy male volunteers

Secondary objective : To investigate safety profiles after the administration of valsartan or rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy male volunteers


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Multiple Dose, Cross-over, Phase I Trial to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
Study Start Date : September 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011


Arm Intervention/treatment
Experimental: Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 7 days.
Drug: Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Experimental: Rosuvastatin 20mg
Rosuvastatin 20mg is administered daily by mouth once a day for 7 days.
Drug: Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Experimental: Valsartan 160mg
Valsartan 160mg is administered daily by mouth once a day for 7 days.
Drug: Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor

Drug: Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other Names:
  • V= Valsartan = brand name : Diovan
  • R= Rosuvastatin = brand name : Crestor




Primary Outcome Measures :
  1. PK parameters of valsartan and rosuvastatin [ Time Frame: 0h (pre-dosing on 6d, 20d, 34d) and 0h (pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 48h, and 72h (on 7d, 21d, 35d). Day 1 0h (only in period 1) ]
    Cmax,ss and AUCτ,ss of valsartan and rosuvastatin


Secondary Outcome Measures :
  1. PK parameters of valsartan and rosuvastatin [ Time Frame: 0h (pre-dosing on 6d, 20d, 34d) and 0h (pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 48h, and 72h (on 7d, 21d, 35d). Day 1 0h (only in period 1) ]
    • Tmax,ss, Cmin,ss, t1/2,β of valsartan and rosuvastatin
    • Cmax,ss and AUCτ,ss of N-desmethyl rosuvastatin


Other Outcome Measures:
  1. Safety [ Time Frame: -1d and 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 10d of Period 1, 2, 3 and 42±2d ]
    1. Adverse event monitoring
    2. Clinical laboratory test
    3. Vital signs
    4. Electrocardiography
    5. Physical examination



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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 of 20 to 45 years of age at screening
  2. 19 kg/m2 ≤ BMI≤ 27 kg/m2 at screening
  3. 90 mmHg ≤SBP<140 mmHg and 60 mmHg ≤DBP<90 mmHg at sitting position at screening
  4. At screening

    • AST and ALT ≤ 1.5 times of upper normal limit
    • Serum total bilirubin ≤ 1.5 times of upper normal limit
    • CK ≤ 2 times of upper normal limit
  5. A subject who is able to understand the study, to participate whole periods of the study and to provide written informed consent voluntarily after being fully informed of the study objectives, procedures and study drug

Exclusion Criteria:

  1. A subject who has medical history of or has clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrinological, neurologic, hematologic/oncologic, or cardiovascular disease
  2. A subject with severe renal insufficiency (CrCL < 10mL/min by Cockcroft-Gault estimation)
  3. A subject with a history of gastrointestinal disease (e.g., ulcer, Crohn's disease) or surgery (except a simple appendectomy or repair of a hernia) that may influence the absorption of the study drug
  4. A subject with a history of drug allergies to valsartan, rosuvastatin, or other drugs (e.g., aspirin, antibiotics), or a history of clinically significant allergies
  5. A subject with a history of drug abuse or a positive urine drug screen for barbiturate, benzodiazepine, methamphetamine, cannabinoids, cocaine, or opiate
  6. A subject who has taken any prescribed medication or herbal compounds within 14 days before the first drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplement within 7 days before the first drug administration. (However, investigators made the final decision on the eligibility for the trial if all other conditions were satisfied)
  7. A subject who has participated in any other clinical trial and received study drug within 60 days before the first drug administration
  8. A subject who has donated a unit of blood or blood components within 60 days or 30 days, respectively, or received a transfusion before the first drug administration
  9. A subject who has taken the drug which inhibits or induces drug metabolism such as barbital
  10. A subject with unusual dietary habit which may influence on the administration, distribution, metabolism or excretion of drugs
  11. A subject who consumes caffeine excessively (> 5 units/day)
  12. A subject with consumes alcohol excessively (> 21 units/week, 1 unit = 10 mL of pure alcohol) or with a history of alcoholism
  13. A heavy smoker ( >10 cigarettes/day)
  14. A subject of positive result in serology tests (HBV, HCV, HIV, or syphilis)
  15. A subject who has hereditary muscle disease or family history of hereditary muscle disease, or who has history of muscle disorder induced by drug
  16. The investigator determines whether or not the subject is eligible for the study after, for example, reviewing clinical laboratory results, ECG result, or for other reason

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): NCT01918709


Locations
Layout table for location information
Korea, Republic of
Clinical Trial Center, Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
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Principal Investigator: Jae-Wook Ko, Professor Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center
Layout table for additonal information
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01918709    
Other Study ID Numbers: LG-VRCL001
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: August 8, 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