HypertensionPhase 1NCT01609907

Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan

A Phase 1 study testing Rosuvastatin+Valsartan (Sequence 1), Rosuvastatin+Valsartan (Sequence 2) and Rosuvastatin+Valsartan (Sequence 3) in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation 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

The objective of this study is to compare pharmacokinetics after single oral administration of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and valsartan in healthy male volunteers. Read more about this study

Who is it for?: Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension, Hyperlipidemia
What is being tested?: Rosuvastatin+Valsartan (Sequence 1), Rosuvastatin+Valsartan (Sequence 2) and Rosuvastatin+Valsartan (Sequence 3)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: Nov 2011to May 2012
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male volunteers of aged between 20 years to 50 years
Have a body mass index (BMI) between 19kg/m2 and 27kg/m2 inclusive
Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period
Able to follow instruction and can participate in whole procedure of the trial
Have signed a written informed consent voluntary, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the drug
Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study

Who cannot join

Have history of cardiovascular disorder(congestive heart failure, complications of coronary artery stenosis stroke and etc.), respiratory disorder, renal disorder(severe renal failure and etc.), liver disorder(moderate or severe liver failure and etc.) endocrine system disorder(diabetics, impaired glucose tolerance and etc.), digestive system disorder, central nervous system disorder, mental illness or malignant tumor
Have history of gastrointestinal disease(Crohn's disease, ulcer and etc.), gastrointestinal surgery(simple appendectomy or herniotomy excluded) that can affect the absorption of the drug
Have suffered from a clinically significant disease within 30 days prior to the first administration
Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with rosuvastatin or valsartan, or other drug(aspirin, antibiotics and etc.)
Have genetic myopathy, family history of myopathy, or history of myopathy to drugs
Have systolic blood pressure higher than 150mmHg or lower than 90mmHg, or diastolic blood pressure higher than 100mmHg or lower than 60mmHg, or pulse rate more than 100times/min or less than 40times/min

Show all 17Show fewer

Have history of drug abuse or shown positive on drug abuse during drug screening test
Participated in any other clinical trials within 90 days prior to the first administration
Have used any herbal medicine, prescription drug, or generic medicine within 30 days, 14 days or 7 days prior to the first administration, respectively (provided, however, if other conditions are judged to be eligible by investigators, subjects can participate in the trial)
Donated whole blood or blood component within 60 days or 30 days prior to the first administration, respectively, or received transfusion within 30 days prior to the first administration
Excessive alcohol drinker(> 140g/week; 1 glass of 12° wine(125mL) = 12.0g, 1 glass of 4° beer(250mL) = 8g, 0.5 bottle of soju(180mL) = 28.8g)
Heavy smoker(> 20 cigarettes/day)
Excessive caffeine drinker(> 4 cups/day)
Shown positive on serum test(HBsAg, HCV Ab, HIV Ab tests)
Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal values in clinical laboratory test
Continuous increase of liver enzyme level(AST, ALT) of unknown cause or active liver disorder patients with liver enzyme level increasing more than 3 time of normal upper limit
Severe renal disorder patients(with creatinine clearance (Cr) < 10mL/min when calculated with Modification of Diet in Renal Disease method)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Yuhan Corporation
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan in Healthy Male Volunteer

Conditions: Hypertension, Hyperlipidemia
Being tested: Rosuvastatin+Valsartan (Sequence 1), Rosuvastatin+Valsartan (Sequence 2), Rosuvastatin+Valsartan (Sequence 3), Rosuvastatin+Valsartan (Sequence 4), Rosuvastatin+Valsartan (Sequence 5)
Keywords: Drug interaction, YH14700, Rosuvastatin, Valsartan, Yuhan
Medical subject headings: Hypertension, Hyperlipidemias

What participants receive

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

Rosuvastatin+Valsartan (Sequence 1)Drug
Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Rosuvastatin+Valsartan (Sequence 2)Drug
Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Rosuvastatin+Valsartan (Sequence 3)Drug
Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Rosuvastatin+Valsartan (Sequence 4)Drug
Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Rosuvastatin+Valsartan (Sequence 5)Drug
Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Rosuvastatin+Valsartan (Sequence 6)Drug
Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

Study groups in NCT01609907
Study group	Role	What they receive
Sequence 1	Experimental	Not described Receives: Drug: Rosuvastatin+Valsartan (Sequence 1)
Sequence 2	Experimental	Not described Receives: Drug: Rosuvastatin+Valsartan (Sequence 2)
Sequence 3	Experimental	Not described Receives: Drug: Rosuvastatin+Valsartan (Sequence 3)
Sequence 4	Experimental	Not described Receives: Drug: Rosuvastatin+Valsartan (Sequence 4)
Sequence 5	Experimental	Not described Receives: Drug: Rosuvastatin+Valsartan (Sequence 5)
Sequence 6	Experimental	Not described Receives: Drug: Rosuvastatin+Valsartan (Sequence 6)

What is being measured

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

Cmax,ss of valsartan
Measured: 18 points up to Day 4
AUCt,ss of valsartan
Measured: 18 points up to Day 4
Cmax,ss of rosuvastatin
Measured: 18 points up to Day 4
AUCt,ss of rosuvastatin
Measured: 18 points up to Day 4
t1/2 of rosuvastatin
Measured: 18 points up to Day 4

Secondary outcomes (8)

Tmax,ss of valsartan
Measured: 18 points up to Day 4
t1/2 of valsartan
Measured: 18 points up to Day 4
Cmin,ss of valsartan
Measured: 18 points up to Day 4
Tmax,ss of rosuvastatin
Measured: 18 points up to Day 4
Cmin,ss of rosuvastatin
Measured: 18 points up to Day 4
t1/2 of rosuvastatin
Measured: 18 points up to Day 4
Cmax,ss of N-desmetyl rosuvastatin
Measured: 18 points up to Day 4
AUCt,ss of N-desmetyl rosuvastatin
Measured: 18 points up to Day 4

Timeline

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

Nov 2011May 2012

First posted1 Jun 2012 (estimated)
Study startNov 2011
Primary completionMay 2012
Study completionMay 2012

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.
More trials run by Yuhan CorporationThe sponsor's other registered studies.
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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01609907
Sponsor's protocol ID: YH14700-101
Status last verified: Jan 2012
First submitted: 5 Jan 2012
Last updated: 1 Jun 2012
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?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan in Healthy Male Volunteer
ClinicalTrials.gov ID: NCT01609907
Acronym / sponsor ID: YH14700-101
Conditions: Hypertension, Hyperlipidemia
Keywords: Drug interaction, YH14700, Rosuvastatin, Valsartan, Yuhan
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Yuhan CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 1 Jun 2012 (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: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: Rosuvastatin+Valsartan (Sequence 1)
Sequence 2	Experimental	Drug: Rosuvastatin+Valsartan (Sequence 2)
Sequence 3	Experimental	Drug: Rosuvastatin+Valsartan (Sequence 3)
Sequence 4	Experimental	Drug: Rosuvastatin+Valsartan (Sequence 4)
Sequence 5	Experimental	Drug: Rosuvastatin+Valsartan (Sequence 5)
Sequence 6	Experimental	Drug: Rosuvastatin+Valsartan (Sequence 6)

Who may qualify

Ages: 20 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy male volunteers of aged between 20 years to 50 years
Have a body mass index (BMI) between 19kg/m2 and 27kg/m2 inclusive
Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period
Able to follow instruction and can participate in whole procedure of the trial
Have signed a written informed consent voluntary, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the drug

Key exclusion criteria (17 listed)

Have history of cardiovascular disorder(congestive heart failure, complications of coronary artery stenosis stroke and etc.), respiratory disorder, renal disorder(severe renal failure and etc.), liver disorder(moderate or severe liver failure and etc.) endocrine system disorder(diabetics, impaired glucose tolerance and etc.), digestive system disorder, central nervous system disorder, mental illness or malignant tumor
Have history of gastrointestinal disease(Crohn's disease, ulcer and etc.), gastrointestinal surgery(simple appendectomy or herniotomy excluded) that can affect the absorption of the drug
Have suffered from a clinically significant disease within 30 days prior to the first administration
Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with rosuvastatin or valsartan, or other drug(aspirin, antibiotics and etc.)
Have genetic myopathy, family history of myopathy, or history of myopathy to drugs

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
Rosuvastatin+Valsartan (Sequence 1)Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)	Drug	Sequence 1
Rosuvastatin+Valsartan (Sequence 2)Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)	Drug	Sequence 2
Rosuvastatin+Valsartan (Sequence 3)Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)	Drug	Sequence 3
Rosuvastatin+Valsartan (Sequence 4)Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)	Drug	Sequence 4
Rosuvastatin+Valsartan (Sequence 5)Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)	Drug	Sequence 5
Rosuvastatin+Valsartan (Sequence 6)Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)	Drug	Sequence 6

Primary outcome

Cmax,ss of valsartan
Time frame: 18 points up to Day 4
AUCt,ss of valsartan
Time frame: 18 points up to Day 4
Cmax,ss of rosuvastatin
Time frame: 18 points up to Day 4
AUCt,ss of rosuvastatin
Time frame: 18 points up to Day 4
t1/2 of rosuvastatin
Time frame: 18 points up to Day 4

8 secondary outcomes

Tmax,ss of valsartan
Time frame: 18 points up to Day 4
t1/2 of valsartan
Time frame: 18 points up to Day 4
Cmin,ss of valsartan
Time frame: 18 points up to Day 4
Tmax,ss of rosuvastatin
Time frame: 18 points up to Day 4
Cmin,ss of rosuvastatin
Time frame: 18 points up to Day 4
t1/2 of rosuvastatin
Time frame: 18 points up to Day 4
Cmax,ss of N-desmetyl rosuvastatin
Time frame: 18 points up to Day 4
AUCt,ss of N-desmetyl rosuvastatin
Time frame: 18 points up to Day 4

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 1 Jun 2012.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Woo-Seung Huh, MD, PhD. principal investigator

Samsung Medical Center

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 6 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 1 Jun 2012. 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,ss of valsartan (time frame: 18 points up to Day 4). The study lists 5 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 NCT01609907.

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 1 Jun 2012.