Pharmacokinetic Study for Anti-tuberculosis Drugs
Information source: Taipei Medical University WanFang Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Tuberculosis
Intervention: Rifater and EMB (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Taipei Medical University WanFang Hospital Official(s) and/or principal investigator(s): Ming-Chih MC Yu, M.D., Principal Investigator, Affiliation: Taipei Medical University- Wan Fang Hospital
Overall contact: Ming-Chih MC Yu, M.D., Phone: +886-2-29307930, Ext: 52953, Email: yutbc@ms10.hinet.net
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: The maximum concentration (Cmax)of first-line TB drugs
Secondary outcome: N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Ming-Chih MC Yu, M.D., Phone: +886-2-29307930, Ext: 52953, Email: yutbc@ms10.hinet.net
Taipei Medical University- Wan Fang Hospital, Taipei 116, Taiwan; Recruiting Ming-Chih Yu, M.D., Phone: +886-2-29307930, Ext: 52953, Email: yutbc@ms10.hinet.net Li-Chun Wu, MPH, Phone: +886-2-82300120, Email: tar266@ms65.hinet.net Ming-Chih Yu, M.D., Principal Investigator H-Eugene Liu, PhD, Sub-Investigator
Additional Information
Starting date: July 2009
Last updated: April 11, 2011
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