NCT00938197

Brief Summary

To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

June 1, 2009

Completed
1 month 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
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 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)

  • AUCss, Cmax,ss, Tmax,ss, CLss/F

    Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day

Study Arms (2)

Part A

ACTIVE COMPARATOR
Drug: Fimasartan

Part B

ACTIVE COMPARATOR
Drug: Amlodipine

Interventions

FimasartanDRUG

Fimasartan (1d\~7d) Amlodipine (12d\~14d) Fimasartan + Amlodipine(15d\~21d)

Part A
AmlodipineDRUG

Amlodipine (1d\~10d) Amlodipine (25d\~27d) Fimasartan + Amlodipine(28d\~34d)

Part B

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 amlodipine
  • 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

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Yi S, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011 Jun;57(6):682-9. doi: 10.1097/FJC.0b013e31821795d0.

    PMID: 21394036DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartanAmlodipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

KR(1)