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

Sponsor
Pfizer
Study ID
NCT07594769
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ODT2 Test formulation — DRUG
    Test Formulation
  • ODT Reference formulation — DRUG
    Reference Formulation

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
May 8, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment Sequence 1
  • Experimental: Treatment Sequence 2

Primary Outcome Measure

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations [ Time Frame: Pre-dose to 72 hours ]

Central Contacts

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