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

Hypertension, Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918709
• Other study ID #: LG-VRCL001
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2013
• Last updated: August 6, 2013
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias
• Hypertension, Hyperlipidemia

Intervention

Drug:
• Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
• Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
• Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
• Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
• Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
• Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Adverse event monitoring; Clinical laboratory test; Vital signs; Electrocardiography; Physical examination	-1d and 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 10d of Period 1, 2, 3 and 42±2d	No
Primary	PK parameters of valsartan and rosuvastatin	Cmax,ss and AUCt,ss of valsartan and rosuvastatin	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)	No
Secondary	PK parameters of valsartan and rosuvastatin	Tmax,ss, Cmin,ss, t1/2,ß of valsartan and rosuvastatin; Cmax,ss and AUCt,ss of N-desmethyl rosuvastatin	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)	No