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About
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
Full description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral granules of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fasting conditions.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Subjects must fulfill the following criteria to be considered for inclusion into this study.
or is postmenopausal for at least 1 year. or is surgically . sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the study volunteer).
Exclusion Criteria The subjects were excluded based on the following criteria.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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