- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01148368
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
January 6, 2012 updated by: Boryung Pharmaceutical Co., Ltd
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
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
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Seoul, Korea, Republic of
- Seoul National University Hospital
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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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
<Renal impairment patient>
- age: 20-65 years
- eGFR: < 30ml/min/1.73m^2
- not on dialysis
- body weight: greater than 55kg
- written informed consent
<Healthy volunteer>
- age: 20-65 years
- body weight: greater than 55kg
- written informed consent
Exclusion Criteria:
- AST, ALT > 1.5 times of upper normal range
- positive drug or alcohol screening
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
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: renal impairment patients
renal impairment patients who eGFR is lower than 30 ml/min/1.73m^2
without hemodialysis
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single administration of fimasartan 120mg
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ACTIVE_COMPARATOR: healthy volunteers
healthy volunteers group
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single administration of fimasartan 120mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pharmacokinetic characteristic of fimasartan
Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h
|
AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan
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0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yon Su Kim, PhD, Seoul National University College of Medicine
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
June 1, 2010
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2011
Study Registration Dates
First Submitted
June 21, 2010
First Submitted That Met QC Criteria
June 21, 2010
First Posted (ESTIMATE)
June 22, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 9, 2012
Last Update Submitted That Met QC Criteria
January 6, 2012
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A657-BR-CT-113
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.
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