A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects
A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hypertension
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 9, 2018
January 1, 2018
3 months
September 28, 2016
January 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cmax and AUClast of Fimasartan, Amlodipine
Time Frame: 0~144 hour after medication
Study Arms (3)
Sequence A
EXPERIMENTALPeriod 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 14 days between the each period.
Sequence B
EXPERIMENTALPeriod 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 14 days between the each period.
Sequency C
EXPERIMENTALPeriod 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 14 days between the each period.
Interventions
Eligibility Criteria
You may qualify if:
- Male 19-50 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- Medically healthy with no clinically significant medical history.
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
You may not qualify if:
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
- Plasma donation within a month prior to the first dose of study drug.
- Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Sang Yu, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2016
First Posted
September 30, 2016
Study Start
October 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
January 9, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share