Hypertension, HyperlipidemiaPhase 1NCT01918709
Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
A Phase 1 study testing Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R), Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R) and Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V) in people with Hypertension, Hyperlipidemia, run by LG Life Sciences at 1 site in South Korea.
Trial 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… 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(V) Period 2(R) Period 3(V+R), Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R) and Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Nov 2011
- 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 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
Who cannot join
- 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)
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- 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
- The investigator determines whether or not the subject is eligible for the study after, for example, reviewing clinical laboratory results, ECG result, or for other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Sequence 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)
- 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(V) Period 2(R) Period 3(V+R)Drug
Also called V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)Drug
Also called V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)Drug
Also called V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)Drug
Also called V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)Drug
Also called V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)Drug
Also called V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : Crestor
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
| Study group | Role | What they receive |
|---|---|---|
| Valsartan 160mg, Rosuvastatin 20mg | Experimental | Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 7 days. Receives: 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of valsartan and rosuvastatin
Cmax,ss and AUCτ,ss of valsartan and rosuvastatin
Measured: 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
- Tmax,ss, Cmin,ss, t1/2,β of valsartan and rosuvastatin
- Cmax,ss and AUCτ,ss of N-desmethyl rosuvastatin
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, HyperlipidemiaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Wook Ko, Professor, Principal investigator, Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918709
- Sponsor's protocol ID
- LG-VRCL001
- Status last verified
- Aug 2013
- First submitted
- 22 Jul 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01918709
- Acronym / sponsor ID
- LG-VRCL001
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valsartan 160mg, Rosuvastatin 20mg | Experimental | 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)Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 7 days. |
| Rosuvastatin 20mg | Experimental | 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 is administered daily by mouth once a day for 7 days. |
| Valsartan 160mg | Experimental | 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 is administered daily by mouth once a day for 7 days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (16 listed)
- 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
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(V) Period 2(R) Period 3(V+R)Also: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : CrestorValsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug | Drug | Rosuvastatin 20mg, Valsartan 160mg, Valsartan 160mg, Rosuvastatin 20mg |
| Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)Also: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : CrestorValsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug | Drug | Rosuvastatin 20mg, Valsartan 160mg, Valsartan 160mg, Rosuvastatin 20mg |
| Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)Also: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : CrestorValsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug | Drug | Rosuvastatin 20mg, Valsartan 160mg, Valsartan 160mg, Rosuvastatin 20mg |
| Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)Also: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : CrestorValsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug | Drug | Rosuvastatin 20mg, Valsartan 160mg, Valsartan 160mg, Rosuvastatin 20mg |
| Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)Also: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : CrestorValsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug | Drug | Rosuvastatin 20mg, Valsartan 160mg, Valsartan 160mg, Rosuvastatin 20mg |
| Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)Also: V= Valsartan = brand name : Diovan, R= Rosuvastatin = brand name : CrestorValsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug | Drug | Rosuvastatin 20mg, Valsartan 160mg, Valsartan 160mg, Rosuvastatin 20mg |
Primary outcome
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
1 secondary outcome
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)
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 8 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.
Jae-Wook Ko, Professor principal investigator
Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R), Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R) and Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V) in people with Hypertension, Hyperlipidemia, run by LG Life Sciences at 1 site in South Korea.
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 8 inclusion and 16 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 8 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2013.