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Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

2014-07-24 14:01:12 | BioPortfolio

Summary

The purpose of this study is:

- To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily (BID) to MDR TB patients refractory to treatment with an optimized background regimen of anti-TB medications (OBR).

- To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.

Study Design

Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tuberculosis

Intervention

OPC-67683

Location

Infectology Center of Latvia - Clinic of Tuberculosis and Lung Diseases
Tinuzi Ogre District
Latvia
LV 5015

Status

Recruiting

Source

Otsuka Pharmaceutical Development & Commercialization, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:12-0400

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TUBERCULOSIS that involves any region of the GASTROINTESTINAL TRACT, mostly in the distal ILEUM and the CECUM. In most cases, MYCOBACTERIUM TUBERCULOSIS is the pathogen. Clinical features include ABDOMINAL PAIN; FEVER; and palpable mass in the ileocecal area.

Tuberculosis of the mouth, tongue, and salivary glands.

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