A Study to Evaluate the Effect of Ketoconazole and Rifamp... | NCT00938262

Studies
A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

NCT00938262

Sponsor

Boryung Pharmaceutical Co., Ltd

Status

Completed

Last Update Posted

Oct 8, 2009Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Essential Hypertension

Interventions

Fimasartan, Ketoconazole, Rifampicin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 10, 2009

First Submission Date that Met QC Criteria

Jul 10, 2009

First Posted Date

Jul 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2009

Last Update Posted Date

Oct 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fimasartan, Ketoconazole, Rifampicin	Experimental		Drug: Fimasartan, Ketoconazole, Rifampicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fimasartan, Ketoconazole, Rifampicin	Drug	Fimasartan (1 day) Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day) Rifampicin (9 days) Rifampicin + Fimasartan (1 day)	Fimasartan, Ketoconazole, Rifampicin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 20 - 45 years
sex: male
body weight: greater than 55 kg
written informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C558933	fimasartan
D007654	Ketoconazole
D012293	Rifampin

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D012294	Rifamycins

Browse Leaves

Not provided

Browse Branches

Not provided