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Completed

NCT Number: NCT01932268

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

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

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Key information

Conditions

Chronic Kidney Disease Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Infections Kidney Diseases Male Urogenital Diseases Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Tuberculosis Urogenital Diseases Urologic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifampicin

Drug

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

Other names: Rifampin

Primary outcomes

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

    Time frame: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2013
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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