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

Phase 1

Completed

• Conditions: Hypertension, Hyperlipidemia

• Registration Number: NCT01918709
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2013-07-22
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Study First Posted: 2013-08-08
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
PK parameters 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)	Cmax,ss and AUCτ,ss of valsartan and rosuvastatin

Secondary Outcome Measures

Name	Time	Method
PK parameters 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)	* Tmax,ss, Cmin,ss, t1/2,β of valsartan and rosuvastatin; * Cmax,ss and AUCτ,ss of N-desmethyl rosuvastatin

Trial Locations

Locations (1)

Clinical Trial Center, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of