Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg

NCT01918358 | Completed Phase 1

• 1 other identifier: LG-VRCL005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab 160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and Crestor® (Rosuvastatin) 20 mg in healthy male volunteers

Conditions

Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Cmax of valsartan and rosuvastatin

  0h(pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 12h, 24h, 48h for each period (total 16 times)

• AUC last of valsartan and rosuvastatin

  0h(pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 12h, 24h, 48h for each period (total 16 times)

Other Outcomes (1)

• Safety evaluation

  -28~-2d, 1d, 2d, 3d, 8d, 9d, 10d, 15d, 16d, 17d, 21 ± 2d

Study Arms (3)

Fixed-dose combination VR 160/20 mg-1

EXPERIMENTAL

Fixed-dose combination VR 160/20 mg-1 is administered by mouth at Day 1, 8 and 15.

Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R); Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1); Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1); Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ); Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ); Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)

Fixed-dose combination VR 160/20 mg-2

EXPERIMENTAL

Fixed-dose combination VR 160/20 mg-2 is administered by mouth at Day 1, 8 and 15.

Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R); Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1); Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1); Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ); Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ); Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)

Valsartan 160mg placebo + Rosuvastatin 20mg

EXPERIMENTAL

Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered by mouth at Day 1, 8 and 15.

Drug: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R); Drug: Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1); Drug: Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1); Drug: Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ); Drug: Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ); Drug: Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)

Interventions

Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R) DRUG

Also known as: Rovatitan tab, Diovan, Crestor

Fixed-dose combination VR 160/20 mg-1; Fixed-dose combination VR 160/20 mg-2; Valsartan 160mg placebo + Rosuvastatin 20mg

Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1) DRUG

Also known as: Rovatitan tab, Diovan, Crestor

Fixed-dose combination VR 160/20 mg-1; Fixed-dose combination VR 160/20 mg-2; Valsartan 160mg placebo + Rosuvastatin 20mg

Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1) DRUG

Also known as: Rovatitan tab, Diovan, Crestor

Fixed-dose combination VR 160/20 mg-1; Fixed-dose combination VR 160/20 mg-2; Valsartan 160mg placebo + Rosuvastatin 20mg

Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ) DRUG

Also known as: Rovatitan tab, Diovan, Crestor

Fixed-dose combination VR 160/20 mg-1; Fixed-dose combination VR 160/20 mg-2; Valsartan 160mg placebo + Rosuvastatin 20mg

Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ) DRUG

Also known as: Rovatitan tab, Diovan, Crestor

Fixed-dose combination VR 160/20 mg-1; Fixed-dose combination VR 160/20 mg-2; Valsartan 160mg placebo + Rosuvastatin 20mg

Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2) DRUG

Also known as: Rovatitan tab, Diovan, Crestor

Fixed-dose combination VR 160/20 mg-1; Fixed-dose combination VR 160/20 mg-2; Valsartan 160mg placebo + 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 aged 20\~45 years at screening
• kg/m2 ≤ BMI ≤27 kg/m2 at screening
• Subject who is able to communicate with investigators and understand the nature of the clinical study and is willing and able to provide a written informed consent form

You may not qualify if:

• Subject with current or previous clinically significant diseases in liver, renal, neurologic, pulmonary, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, psychological, and musculoskeletal system
• Patient with renal defects (Calculated GFR \< 60 ml/min based on serum creatinine level )
• Subject who can not satisfy the following criteria for sitting blood pressure at screening test 90 ≤SBP \<140 (mmHg) 60 ≤ DBP \<90 (mmHg)
• Subject who can not satisfy the following criteria at screening 1) AST and ALT ≤ 1.5x ULN 2) Serum total bilirubin ≤ 1.5x ULN 3) CK (Creatinine kinase) ≤ 2x ULN
• Subject with a medical history of gastrointestinal diseases (e.g., Crohn's disease, ulcer) or a surgery (for appendicitis and hernia repair are allowed) that might affect the investigational product absorption
• Subject with hypersensitivity to the drugs containing components of valsartan and rosuvastatin or other drugs (aspirin, antibiotics) or a previous clinically significant history of hypersensitivity
• Subject with a previous history of drug overdose or a positive to the drugs (Barbiturate, Benzodiazepine, Methamphetamine, Cannabinoids, Cocaine, Opiate) in urine drug screening test
• Subject who has taken any prescribed medicines or oriental medicines within two weeks before the first investigational product administration, or who has taken any over-the-counter drugs within one week before the first investigational product administration (If the subject is eligible for all other criteria, he or she may participate in the clinical study based on investigator's discretion.)
• Subject who has taken other investigational products within 60 days before the first investigational product administration
• Subject who donated whole blood within 60 days or donated apheresis blood within 30 days or received a transfusion within 30 days before the first investigational product administaration.
• Subject who has taken the drugs that induce or inhibit drug-metabolizing enzymes such as barbiturates within 30 days before the first investigational product administration
• Subject with a daily intake of drinks containing caffeine (coffee, tea, coke) or grapefruit juice \> average of 4 cups / day (800 mL) or a subject who can not discontinue such drinks during the clinical study period(from screening to post-study visit)
• Subject with a mean weekly drinking amount of \> 140g or a subject who can not stop drinking until outpatient visit after the investigational product administration, including the hospitalization in each period.
• Subject with a mean daily smoking amount of \> 10 cigarettes or a subject who can not stop smoking during the hospitalization
• Subject positive result in serology tests (hepatitis B, hepatitis C, HIV)

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Valsartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

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: August 5, 2013
• First Posted: August 7, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

KR (1)