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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

Page last updated: August 23, 2015

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