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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Tuberculosis

Treatments: Drug: Rifampicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01932268

Colchicine_RFP 2011_1

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2 participants in 1 patient group

Rifampicin

Experimental group

Description:

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

Treatment:

Drug: Rifampicin