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

LG Life Sciences1 site in 1 country30 target enrollmentSeptember 2011

DrugsSequence 1 : Period 1(V) Period 2(R) Period 3(V+R)Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypertension, Hyperlipidemia
Sponsor: LG Life Sciences
Enrollment: 30
Locations: 1
Primary Endpoint: PK parameters of valsartan and rosuvastatin
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

November 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

LG Life Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male of 20 to 45 years of age at screening
•19 kg/m2 ≤ BMI≤ 27 kg/m2 at screening
•90 mmHg ≤SBP\<140 mmHg and 60 mmHg ≤DBP\<90 mmHg at sitting position at screening
•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
•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

•A subject who has medical history of or has clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrinological, neurologic, hematologic/oncologic, or cardiovascular disease
•A subject with severe renal insufficiency (CrCL \< 10mL/min by Cockcroft-Gault estimation)
•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
•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
•A subject with a history of drug abuse or a positive urine drug screen for barbiturate, benzodiazepine, methamphetamine, cannabinoids, cocaine, or opiate
•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)
•A subject who has participated in any other clinical trial and received study drug within 60 days before the first drug administration
•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
•A subject who has taken the drug which inhibits or induces drug metabolism such as barbital
•A subject with unusual dietary habit which may influence on the administration, distribution, metabolism or excretion of drugs

Outcomes

Primary Outcomes

PK parameters of valsartan and rosuvastatin

Time Frame: 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 Outcomes

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))