Pharmacokinetic Study for Anti-tuberculosis Drugs - Full Text View

Sponsor:	Taipei Municipal Wan Fang Hospital
Information provided by:	Taipei Municipal Wan Fang Hospital
ClinicalTrials.gov Identifier:	NCT00948077

Purpose

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	Intervention
Pulmonary Tuberculosis	Behavioral: time of taking drugs

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Further study details as provided by Taipei Municipal Wan Fang Hospital:

Primary Outcome Measures:

The maximum concentration (Cmax)of first-line TB drugs [ Time Frame: Before and 1, 2, 4, 6 and 10 hours after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined. [ Time Frame: Before taking the anti-TB drugs on the fifth day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment A: Active Comparator Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."	Behavioral: time of taking drugs 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)
Treatment B: Experimental Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."	Behavioral: time of taking drugs 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)

Arms

Assigned Interventions

Treatment A: Active Comparator

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

Behavioral: time of taking drugs

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)

Treatment B: Experimental

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

Behavioral: time of taking drugs

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)

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948077

Contacts

Contact: Ming-Chih MC Yu, M.D.

+886-2-29307930 ext 52953

yutbc@ms10.hinet.net

Locations

Taiwan
Taipei Medical University- Wan Fang Hospital
Taipei, Taiwan, 116

Sponsors and Collaborators

Taipei Municipal Wan Fang Hospital

Investigators

Principal Investigator:

Ming-Chih MC Yu, M.D.

Taipei Medical University- Wan Fang Hospital

More Information

No publications provided

Responsible Party:	Division of Pulmonary Medicine ( Ming-Chih Yu, M.D./Chief )
Study ID Numbers:	2009WFCRC-08, 98040
Study First Received:	June 16, 2009
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00948077 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Taipei Municipal Wan Fang Hospital:

tuberculosis
pharmacokinetic
first-line drugs

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Tuberculosis, Pulmonary
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on February 08, 2010