Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
December 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2018
CompletedAugust 10, 2018
August 1, 2018
1 month
December 29, 2017
August 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cmax
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
0~48hours after medication
Secondary Outcomes (1)
AUCt
0~48hours after medication
Study Arms (6)
Arm1(N=6)
OTHERFimasartan/Amlodipine combination drug, Hydrochlorothiazide
Arm2(N=6)
OTHERFimasartan/Amlodipine combination drug, Hydrochlorothiazide
Arm3(N=6)
OTHERFimasartan/Amlodipine combination drug, Hydrochlorothiazide
Arm4(N=6)
OTHERFimasartan/Amlodipine combination drug, Hydrochlorothiazide
Arm5(N=6)
OTHERFimasartan/Amlodipine combination drug, Hydrochlorothiazide
Arm6(N=6)
OTHERFimasartan/Amlodipine combination drug, Hydrochlorothiazide
Interventions
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Eligibility Criteria
You may qualify if:
- A healthy Male adults aged 19-50 years
You may not qualify if:
- History or presence of clinically significant medical or psychiatric condition or disease.
- Hypersensitivity to ingredient of IP and other medication, food.
- Participation in any other study within 3months.
- History of whole blood donation within 2months and Apheresis 1month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inje University Busan Paik Hospital
Busan, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun-Young Kim
Inje University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2017
First Posted
January 4, 2018
Study Start
December 15, 2017
Primary Completion
January 16, 2018
Study Completion
January 30, 2018
Last Updated
August 10, 2018
Record last verified: 2018-08