To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension. To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus the reference sachet formulation (granules)
This is a single center, open-label, single oral dose, 4-period cross-over study to assess the bioequivalence of a new formulation (suspension) in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
53
Racecadotril suspension at 10, 30 and 60mg. Single oral dose.
Racecadotril granules at 60mg. Single oral dose.
Eurofins Optimed
Gières, France
Bio-equivalence
Several blood sample will be collected at each period to investigate the racecadotril pharmacokinetic linearity and to evaluate the comparative bioavalibility. 4-period, cross over, single oral dose at each period.
Time frame: Total study duration per subject should be 6 weeks.
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