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

NCT ID: NCT01918709

Last Updated: 2013-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-11-30

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

Conditions

Hypertension, Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Valsartan 160mg, Rosuvastatin 20mg

Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 7 days.

Group Type: EXPERIMENTAL

Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Rosuvastatin 20mg

Rosuvastatin 20mg is administered daily by mouth once a day for 7 days.

Group Type: EXPERIMENTAL

Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Valsartan 160mg

Valsartan 160mg is administered daily by mouth once a day for 7 days.

Group Type: EXPERIMENTAL

Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)

Intervention Type: DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Interventions

Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Intervention Type: DRUG

Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Intervention Type: DRUG

Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Intervention Type: DRUG

Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Intervention Type: DRUG

Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Intervention Type: DRUG

Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Intervention Type: DRUG

Other Intervention Names

V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae-Wook Ko, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center

Locations

Clinical Trial Center, Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LG-VRCL001

Identifier Type: -

Identifier Source: org_study_id