A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 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
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedOctober 8, 2009
October 1, 2009
2 months
July 10, 2009
October 7, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2
0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h
Study Arms (1)
Fimasartan, Ketoconazole, Rifampicin
EXPERIMENTALInterventions
Fimasartan (1 day) Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day) Rifampicin (9 days) Rifampicin + Fimasartan (1 day)
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, ketoconazole and rifampicin
- 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
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
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
October 8, 2009
Record last verified: 2009-10