HypertensionPhase 1NCT01918358

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

A Phase 1 study testing Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R), Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1) and Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1) in people with Hypertension and Hyperlipidemia, run by LG Life Sciences at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension, Hyperlipidemia
What is being tested?: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R), Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1) and Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSouth Korea
Study dates: Dec 2012to Jan 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male aged 20~45 years at screening
19 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

Who cannot join

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

Show all 17Show fewer

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)
Subject with genetic muscle disease, or familial history of muscle disease, or medical history of drug-derived muscle disorder
Subject who is considered not to be eligible at investigator's discretion.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Samsung Medical Center
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose Crossover Study to Compare the 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 in Healthy Male Volunteers

Conditions: Hypertension, Hyperlipidemia
Being tested: Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R), Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1), Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1), Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ), Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )
Medical subject headings: Hypertension, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)Drug
Also called Rovatitan tab, Diovan, Crestor
Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1)Drug
Also called Rovatitan tab, Diovan, Crestor
Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)Drug
Also called Rovatitan tab, Diovan, Crestor
Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 )Drug
Also called Rovatitan tab, Diovan, Crestor
Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )Drug
Also called Rovatitan tab, Diovan, Crestor
Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)Drug
Also called Rovatitan tab, Diovan, Crestor

Study groups in NCT01918358
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of valsartan and rosuvastatin
Measured: 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
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Jan 2013

First posted7 Aug 2013 (estimated)
Study startDec 2012
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01918358
Sponsor's protocol ID: LG-VRCL005
Status last verified: Aug 2013
First submitted: 5 Aug 2013
Last updated: 7 Aug 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single Dose Crossover Study to Compare the 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 in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT01918358
Acronym / sponsor ID: LG-VRCL005
Conditions: Hypertension, Hyperlipidemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: LG Life SciencesIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Fixed-dose combination VR 160/20 mg-1	Experimental	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-1 is administered by mouth at Day 1, 8 and 15.
Fixed-dose combination VR 160/20 mg-2	Experimental	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 is administered by mouth at Day 1, 8 and 15.
Valsartan 160mg placebo + Rosuvastatin 20mg	Experimental	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)Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered by mouth at Day 1, 8 and 15.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male aged 20~45 years at screening
19 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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)Also: Rovatitan tab, Diovan, Crestor	Drug	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)Also: Rovatitan tab, Diovan, Crestor	Drug	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)Also: Rovatitan tab, Diovan, Crestor	Drug	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 )Also: Rovatitan tab, Diovan, Crestor	Drug	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 )Also: Rovatitan tab, Diovan, Crestor	Drug	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)Also: Rovatitan tab, Diovan, Crestor	Drug	Fixed-dose combination VR 160/20 mg-1, Fixed-dose combination VR 160/20 mg-2, Valsartan 160mg placebo + Rosuvastatin 20mg

Primary outcome

Cmax of valsartan and rosuvastatin
Time frame: 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
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of valsartan and rosuvastatin (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01918358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.