A phase 1, open label, single dose, randomized, crossover study to evaluate the bioequivalence of TWO formulations of a cgrp receptor antagonist in healthy adult participants
Abstract
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.
Conditions: Migraine.
Primary outcome: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations; Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) of the test and reference formulations; Maximum observed plasma concentration (Cmax) of test and reference formulations.
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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