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

NCT01932268 | Completed Phase 2

• 1 other identifier: Colchicine_RFP 2011_1
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Kidney Disease; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Rifampicin

EXPERIMENTAL

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

Drug: Rifampicin

Interventions

Rifampicin DRUG

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

Also known as: Rifampin

Rifampicin

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Tuberculosis

Interventions

Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: August 30, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 30, 2013

Record last verified: 2013-08