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

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Tuberculosis
• Interventions: Drug: Rifampicin

• Registration Number: NCT01932268
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-07
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-26
• Last Update Submitted: 2013-08-26
• Study First Posted: 2013-08-30
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration	the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration