NCT00938132

Brief Summary

To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Status
completed

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

July 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

July 10, 2009

Last Update Submit

October 7, 2009

Conditions

Essential Hypertension

Keywords

fimasartandrug interaction

Outcome Measures

Primary Outcomes (1)

  • INR AUC, INRmax, INRtmax

    pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d

Secondary Outcomes (1)

  • AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin

    pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d

Study Arms (1)

Fimasartan

EXPERIMENTAL
Drug: fimasartan, warfarin

Interventions

fimasartan, warfarinDRUG

Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)

Fimasartan

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age: 20 - 40 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

You may not qualify if:

  • known allergy to Fimasartan and warfarin
  • 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)

  • Choi Y, Han H, Shin D, Lim KS, Yu KS. Comparison of the pharmacokinetics and tolerability of HCP1004 (a fixed-dose combination of naproxen and esomeprazole strontium) and VIMOVO(R) (a marketed fixed-dose combination of naproxen and esomeprazole magnesium) in healthy volunteers. Drug Des Devel Ther. 2015 Jul 31;9:4127-35. doi: 10.2147/DDDT.S86725. eCollection 2015.

    PMID: 26257511DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartanWarfarin

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 8, 2009

Record last verified: 2009-10