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
Overview
- Phase
- Not Applicable
- Intervention
- Rifater and EMB
- Conditions
- Pulmonary Tuberculosis
- Sponsor
- Taipei Medical University WanFang Hospital
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- The maximum concentration (Cmax)of first-line TB drugs
- Last Updated
- 15 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Treatment A
Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."
Intervention: Rifater and EMB
Treatment B
Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."
Intervention: Rifater and EMB
Outcomes
Primary Outcomes
The maximum concentration (Cmax)of first-line TB drugs
Time Frame: Before and 1, 2, 4, 6 and 10 hours after dosing
Secondary Outcomes
- N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.(Before taking the anti-TB drugs on the fifth day)