- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01232049
Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)
June 24, 2011 updated by: Asan Medical Center
A Randomized, Open-label, Multiple Dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Pitavastatin and Valsartan in Healthy Male Subjects
This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Adult males aged 20 to 50 years at screening.
- No significant congenital/chronic disease. No symptoms in physical examination.
- Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
- Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
Exclusion Criteria:
- History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
- History of known hypersensitivity to drugs including valsartan and pitavastatin.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Pitavastatin 4mg
|
Pitavastatin 4mg
Other Names:
Valsartan 320mg
Other Names:
|
Experimental: B
Valsartan 320mg
|
Pitavastatin 4mg
Other Names:
Valsartan 320mg
Other Names:
|
Experimental: C
Pitavastatin 4mg + Valsartan 320mg
|
Pitavastatin 4mg
Other Names:
Valsartan 320mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (normal results for safety tests)
Time Frame: 39days
|
Adverse events Physical examination, vital signs
|
39days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 1, 2010
First Posted (Estimate)
November 2, 2010
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 24, 2011
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010-0577
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Multiple Oral Dose of
-
Galapagos NVCompleted
-
PfizerCompletedFungal InfectionNetherlands
-
Galapagos NVCompleted
-
Astellas Pharma Europe B.V.CompletedPharmacokinetics of ASP1707 | Pharmacodynamics of ASP1707France
-
PfizerCompletedColitis, UlcerativeSpain, Belgium, Germany, Czech Republic, Norway, Denmark, Slovakia
-
PfizerCompleted
-
J2H BiotechCompletedNon-alcoholic SteatohepatitisKorea, Republic of
-
Arthrosi TherapeuticsIqvia Pty LtdCompletedRenal ImpairmentUnited States, New Zealand