Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

Phase 2

Completed

• Conditions: Tuberculosis

• Registration Number: NCT00306319
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

Detailed Description

Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-23
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment.
• Subject is 18-55 years of age at the day of the first dosing of study medication.
• Subject has a normal ECG
• Subjects bodyweight is >35kg
• Use of rifampicin and isoniazid

Exclusion Criteria

• Pregnant or lactating
• History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus.
• Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin.
• Subject is not able and/or not willing to sign the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (24 hrs) curves will be drawn
at day 5 in period I and period II.

Trial Locations

Locations (1)

Rumah Sakit Hasan Sadikin (RSHS); 🇮🇩 Bandung, Indonesia