Status and phase
Conditions
Treatments
About
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Surgically sterilized at least 6 months prior to study participation. Or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
And Serum pregnancy test must be negative.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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