Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
Information source: LG Life Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Hyperlipidemia
Intervention: 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) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: LG Life Sciences Official(s) and/or principal investigator(s): Jae-Wook Ko, Professor, Principal Investigator, Affiliation: Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: PK parameters of valsartan and rosuvastatin
Secondary outcome: PK parameters of valsartan and rosuvastatin
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Clinical Trial Center, Samsung Medical Center, Seoul, Korea, Republic of
Additional Information
Starting date: September 2011
Last updated: August 6, 2013
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