Pharmacokinetic Study for Anti-tuberculosis Drugs (TBPK)

April 11, 2011 updated by: Taipei Medical University WanFang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei medical university- Wan Fang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming-Chih Yu, M.D.
        • Sub-Investigator:
          • H-Eugene Liu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The maximum concentration (Cmax)of first-line TB drugs
Time Frame: Before and 1, 2, 4, 6 and 10 hours after dosing
Before and 1, 2, 4, 6 and 10 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Before taking the anti-TB drugs on the fifth day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Principal Investigator: Ming-Chih MC Yu, M.D., Taipei medical university- Wan Fang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 12, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009WFCRC-08
  • 98040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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