Pharmacokinetic Study for Anti-tuberculosis Drugs (TBPK)
Recruitment status was Recruiting
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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 |
- 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 ]
- 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.
- 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 |
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| Contact: Ming-Chih MC Yu, M.D. | +886-2-29307930 ext 52953 | yutbc@ms10.hinet.net |
| 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 | |
| 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 June 17, 2013