RecruitingPhase 1NCT07594769

A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults

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

Sponsor

Pfizer

Enrollment

36 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

Migraine

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Male or female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
Have a body mass index (BMI) of 16-32 kg/m2, and a body weight >45 kg.

Exclusion Criteria6

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any medical, psychiatric condition, suicidal ideation and behavior, laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
A positive urine drug test. A single repeat for positive drug screen may be allowed.
Unwilling or unable to comply with the Lifestyle Considerations criteria of this study.

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