NCT00948077

Pharmacokinetic Study for Anti-tuberculosis Drugs

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Taipei Medical University WanFang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2009-07-29
• Last updated: 2011-04-12

Locations

1 site across 1 country: Taiwan