Pharmacokinetic Study for Anti-tuberculosis Drugs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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

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

Conditions

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Pulmonary Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment A

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

Group Type ACTIVE_COMPARATOR

Rifater and EMB

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Rifater and EMB

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No