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A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults
Sponsor: Pfizer
Summary
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.
Official title: A PHASE 1, OPEN LABEL, SINGLE DOSE, RANDOMIZED, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF DIFFERENT FORMULATIONS OF A CGRP RECEPTOR ANTAGONIST IN HEALTHY ADULT PARTICIPANTS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-11-24
Completion Date
2026-05-13
Last Updated
2026-02-25
Healthy Volunteers
Yes
Conditions
Interventions
Test formulation (Treatment A)
calcitonin gene-related peptide receptor inhibitor
Reference formulation (Treatment B)
calcitonin gene-related peptide receptor inhibitor
Test formulation (Treatment C)
calcitonin gene-related peptide receptor inhibitor
Test formulation (Treatment D)
calcitonin gene-related peptide receptor inhibitor
Locations (1)
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States