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The purpose of this study is to assess the rate and extent of absorption of bedaquiline following administration of a single oral dose of 100 milligram (mg) equivalent (1*100 mg) given as different test tablet formulations compared to the administration of a single oral dose of 100 mg equivalent (1*100 mg) formulated as SIRTURO commercial tablet (formulation F001), under fasted conditions in healthy adult participants. Also, to assess the effect of a standardized breakfast on the rate and extent of absorption of bedaquiline compared to fasted conditions following administration of a single oral dose of 100 mg equivalent (1*100 mg) for each of the different test tablet formulations.
Bedaquiline (Test formulation), Bedaquiline (Reference formulation)
SGS Life Science Services
Not yet recruiting
Janssen Research & Development, LLC
Published on BioPortfolio: 2019-09-18T03:27:46-0400
The purpose of this study is to assess the effect of steady-state clarithromycin once every 12 hour on the pharmacokinetic parameters of bedaquiline and its active metabolite M2 after a si...
This is a randomized, open-label, cross-over study comparing the bioequivalence of bedaquiline administered in whole tablet form versus bedaquiline administered in crushed (experimental) f...
The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the Reference...
The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy regimen in participants with treatment-naive, multibacillary (MB) leprosy.
This open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of 3 test formulations to a reference formulation of alectinib (RO5424802) i...
Bedaquiline was recommended by WHO as the preferred option in treatment of MDR-TB patients with long regimen. However, no recommendation was given for the short MDR-TB regimen. Data from our small coh...
A continuous effort has been given to find out a new drug that is effective against tuberculosis (TB) from both susceptible and resistant strains of Mycobacterium tuberculosis. Bedaquiline represents ...
: Outcomes of treatment for resistant tuberculosis are poor, with long treatment duration and poor tolerability. Bedaquiline is a novel anti-mycobacterial drug, which has a very long terminal eliminat...
Clinical resistance against Bedaquiline, the first new anti-tuberculosis compound with a novel mechanism of action in over 40 years, has already been detected in Mycobacterium tuberculosis. As a new d...
Two new drugs, delamanid and bedaquiline, have recently been approved for treatment of multidrug-resistant and extensively drug-resistant (XDR) tuberculosis. Here, we report a case of clofazimine, bed...
A type of viscous polysaccharide that is secreted from PLANTS. It has natural properties that are useful in the formulation of ADHESIVES.
A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.
Disorders in which phagocytic cells cannot kill ingested bacteria; characterized by frequent recurring infection with formulation of granulomas.
A field of biological research combining engineering in the formulation, design, and building (synthesis) of novel biological structures, functions, and systems.
Insulin formulation containing substance which delays or retards time period of the absorption of insulin.
Bioscience - any of the sciences that deal with living organisms. The study of the nature, behavior, and uses of living organisms as applied to biology. Any of the branches of natural science dealing with living things, such as their structure, b...