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Pharmacokinetic Study for Anti-tuberculosis Drugs (TBPK)
This study is currently recruiting participants.
Verified April 2011 by Taipei Medical University WanFang Hospital

First Received on June 16, 2009.   Last Updated on April 11, 2011   History of Changes
Sponsor: Taipei Medical University WanFang Hospital
Information provided by: Taipei Medical University WanFang 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
 Drug: Rifater and EMB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis
Drug Information available for: Rifater
U.S. FDA Resources

Further study details as provided by Taipei Medical University WanFang 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 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

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

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.
  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 Recruiting
Taipei, Taiwan, 116
Contact: Ming-Chih Yu, M.D.     +886-2-29307930 ext 52953     yutbc@ms10.hinet.net    
Contact: Li-Chun Wu, MPH     +886-2-82300120     tar266@ms65.hinet.net    
Principal Investigator: Ming-Chih Yu, M.D.            
Sub-Investigator: H-Eugene Liu, PhD            
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming-Chih MC Yu, M.D. Taipei Medical University- Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Ming-Chih Yu, M.D./Chief, Taipei Medical University WanFang Hospital - Division of Pulmonary Medicine
ClinicalTrials.gov Identifier: NCT00948077     History of Changes
Other Study ID Numbers: 2009WFCRC-08, 98040
Study First Received: June 16, 2009
Last Updated: April 11, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
tuberculosis
pharmacokinetic
first-line drugs

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Isoniazid, pyrazinamide, rifampin drug combination
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012



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