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

NCT01918709 | Completed Phase 1

• 1 other identifier: LG-VRCL001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension, Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• PK parameters of valsartan and rosuvastatin

  Cmax,ss and AUCτ,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)

Secondary Outcomes (1)

• 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)

Other Outcomes (1)

• Safety

  -1d and 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 10d of Period 1, 2, 3 and 42±2d

Study Arms (3)

Valsartan 160mg, Rosuvastatin 20mg

EXPERIMENTAL

Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 7 days.

Drug: 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)

Rosuvastatin 20mg

EXPERIMENTAL

Rosuvastatin 20mg is administered daily by mouth once a day for 7 days.

Drug: 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)

Valsartan 160mg

EXPERIMENTAL

Valsartan 160mg is administered daily by mouth once a day for 7 days.

Drug: 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)

Interventions

Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R) DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Also known as: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor

Rosuvastatin 20mg; Valsartan 160mg; Valsartan 160mg, Rosuvastatin 20mg

Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R) DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Also known as: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor

Rosuvastatin 20mg; Valsartan 160mg; Valsartan 160mg, Rosuvastatin 20mg

Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V) DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Also known as: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor

Rosuvastatin 20mg; Valsartan 160mg; Valsartan 160mg, Rosuvastatin 20mg

Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V) DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Also known as: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor

Rosuvastatin 20mg; Valsartan 160mg; Valsartan 160mg, Rosuvastatin 20mg

Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R) DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Also known as: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor

Rosuvastatin 20mg; Valsartan 160mg; Valsartan 160mg, Rosuvastatin 20mg

Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R) DRUG

Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Also known as: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor

Rosuvastatin 20mg; Valsartan 160mg; Valsartan 160mg, Rosuvastatin 20mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male of 20 to 45 years of age at screening
• kg/m2 ≤ BMI≤ 27 kg/m2 at screening
• 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

You may not qualify if:

• 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
• A subject who consumes caffeine excessively (\> 5 units/day)
• A subject with consumes alcohol excessively (\> 21 units/week, 1 unit = 10 mL of pure alcohol) or with a history of alcoholism
• A heavy smoker ( \>10 cigarettes/day)
• A subject of positive result in serology tests (HBV, HCV, HIV, or syphilis)
• A subject who has hereditary muscle disease or family history of hereditary muscle disease, or who has history of muscle disorder induced by drug

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Clinical Trial Center, Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jae-Wook Ko, Professor

  Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: August 8, 2013
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 8, 2013

Record last verified: 2013-08

Locations

KR (1)