A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
1 other identifier
interventional
34
0 countries
N/A
Brief Summary
To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
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 Mar 2009
Shorter than P25 for phase_1
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
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedOctober 8, 2009
October 1, 2009
2 months
June 16, 2009
October 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC, Cmax, Tmax, CL/F
0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day
Study Arms (2)
Part A
ACTIVE COMPARATORFimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)
Part B
ACTIVE COMPARATORHydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day)
Interventions
Eligibility Criteria
You may qualify if:
- age: 20 - 45 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
You may not qualify if:
- known allergy to Fimasartan and hydrochlorothiazide
- existing cardiac or hematological diseases
- existing hepatic and renal diseases
- existing gastrointestinal diseases
- acute or chronic diseases which could affect drug absorption or metabolism
- history of any serious psychological disorder
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day 3 month ago
- participation in a clinical trial during the last 2 months prior to the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gu N, Kim BH, Lim KS, Kim SE, Nam WS, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. The effect of fimasartan, an angiotensin receptor type 1 blocker, on the pharmacokinetics and pharmacodynamics of warfarin in healthy Korean male volunteers: a one-sequence, two-period crossover clinical trial. Clin Ther. 2012 Jul;34(7):1592-600. doi: 10.1016/j.clinthera.2012.06.004. Epub 2012 Jun 22.
PMID: 22727611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 18, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2009
Study Completion
August 1, 2009
Last Updated
October 8, 2009
Record last verified: 2009-10