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A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

NCT ID: NCT01932268

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.

Detailed Description

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Conditions

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Chronic Kidney Disease Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rifampicin

experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin

Group Type EXPERIMENTAL

Rifampicin

Intervention Type DRUG

single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration

Interventions

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Rifampicin

single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration

Intervention Type DRUG

Other Intervention Names

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Rifampin

Eligibility Criteria

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Inclusion Criteria

* from 18yrs to 80yrs , man and women
* the patient who are taking rifampicine over 2weeks
* the patient sign on the concent form

Exclusion Criteria

* the patient have experience to take medication that have an effect on renal function
* the patient have hypersensitivity to colchicine
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* uncontrolled hypertension
* serum albumin \< 3.5, \> 5 g/dL
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Colchicine_RFP 2011_1

Identifier Type: -

Identifier Source: org_study_id