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Pharmacokinetic Study for Anti-tuberculosis Drugs

NCT00948077 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-04-12

No results posted yet for this study

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.

Conditions

  • Pulmonary Tuberculosis

Interventions

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)

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Ming-Chih MC Yu, M.D. · Taipei Medical University- Wan Fang Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00948077 on ClinicalTrials.gov