TBPK: Pharmacokinetic Study for Anti-tuberculosis Drugs

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00948077

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Tuberculosis	Drug: Rifater and EMB	N/A

Detailed Description

This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.

Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast.
Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

A Single-Center, Open-Label, Randomized, Crossover Design Study to Evaluate the Effect of Dietary Status on Pharmacokinetic Profile of Orally Administered First-Line Anti-TB Drugs in Subjects With Pulmonary Tuberculosis

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."	Drug: Rifater and EMB The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day)
Experimental: Treatment B Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."	Drug: Rifater and EMB The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day)

Arm

Intervention/Treatment

Active Comparator: Treatment A

Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."

Drug: Rifater and EMB

The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day)

Experimental: Treatment B

Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."

Drug: Rifater and EMB

Outcome Measures

Primary Outcome Measures

The maximum concentration (Cmax)of first-line TB drugs [Before and 1, 2, 4, 6 and 10 hours after dosing]

Secondary Outcome Measures

N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined. [Before taking the anti-TB drugs on the fifth day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age greater than 20 years
Karnofsky score of > 50
Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
Only subjects who have provided signed and dated written informed consent will be included.

Exclusion Criteria:

Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
Women who are Pregnant or breastfeeding during the study period.
Subjects with a known allergy to study drugs
In the opinion of the investigator to be unsuitable for study participation for any reason.