The purpose of this study is to assess the bioequivalence of an alternative ODT formulation (ODT2) versus the approved ODT formulation of a CGRP receptor antagonist in healthy adult participants under fasting conditions.
To evaluate the bioequivalence of ODT2 (Test) versus approved ODT (Reference) formulations administered on top of the tongue in healthy adult participants under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Test Formulation
Reference Formulation
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
RECRUITINGArea under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations
Time frame: Pre-dose to 72 hours
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) of the test and reference formulations
Time frame: Pre-dose to 72 hours
Maximum observed plasma concentration (Cmax) of test and reference formulations
Time frame: Pre-dose to 72 hours
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: From baseline up to 36 days after last dose of study intervention
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