The purpose of this study is to assess the bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of different formulations of a CGRP receptor antagonist in healthy adult participants. The study is seeking participants who are: 1. Healthy males and females 18 years of age or older 2. Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures. 3. Body Mass Index of 16-32 kilogram per meter squared (kg/m2); and a total body weight \>45 kg The study will help the team understand how difference in formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
calcitonin gene-related peptide receptor inhibitor
calcitonin gene-related peptide receptor inhibitor
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States
RECRUITINGArea under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations
Time frame: Pre-dose to 72 hours
Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (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: Predose to 72 hours
Number of participants with Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Baseline up to 36 days after the last dose of study intervention
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to 36 days after the last dose of study intervention
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