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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Tuberculosis

Intervention: Rifampicin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Seoul National University Hospital


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

Clinical Details

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration


Minimum age: 19 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: January 2011
Last updated: August 26, 2013

Page last updated: August 23, 2015

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