Clinical trial NCT01918709: Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Hyperlipidemia
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-08-08
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: PK parameters of valsartan and rosuvastatin
timeFrame: 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)
Secondary outcomes:
measure: PK parameters of valsartan and rosuvastatin
timeFrame: 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)
Other outcomes:
measure: Safety
timeFrame: -1d and 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 10d of Period 1, 2, 3 and 42±2d
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Samsung Medical Center
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center
name: Jae-Wook Ko, Professor
role: PRINCIPAL_INVESTIGATOR
References: