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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01932268
Enrollment
2
Registered
2013-08-30
Start date
2011-01-31
Completion date
2011-12-31
Last updated
2013-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Tuberculosis

Brief summary

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

Interventions

DRUGRifampicin

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026