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RECRUITING
NCT07261371
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Test formulation (Treatment A)

calcitonin gene-related peptide receptor inhibitor

DRUG

Reference formulation (Treatment B)

calcitonin gene-related peptide receptor inhibitor

DRUG

Test formulation (Treatment C)

calcitonin gene-related peptide receptor inhibitor

DRUG

Test formulation (Treatment D)

calcitonin gene-related peptide receptor inhibitor

Locations (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, United States