Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of
Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in
combination with prednisolone or alone.
Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary
leprosy patients without causing an unacceptably high incidence of adverse effects.
Design is a multicentre hospital-based single-blind prospective trial for leprosy patients
with ENL reaction. prior written consent will be taken from the patients who will undergo the
trial.
Endpoints are decrease in severity of ENL and absence of new nerve function impairment
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Completed
Dr. Reddy's Laboratories Limited
Phase 1
2007-12-01
The objective of this study was to compare the relative bioavailability of zafirlukast
tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy,
adult, human, subjects under fasting conditions and to monitor safety of subjects.
Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil
Completed
Fundação de Amparo à Pesquisa do Estado de São Paulo
Phase 4
2014-08-01
The purpose of this study is to assess whether the switch from branded to generic warfarin or
between different generic warfarin tablets may cause fluctuation in the results of
coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing
them to unnecessary risks.
Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil
Completed
Federal University of São Paulo
Phase 4
2014-08-01
The purpose of this study is to assess whether the switch from branded to generic warfarin or
between different generic warfarin tablets may cause fluctuation in the results of
coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing
them to unnecessary risks.
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