Phase 1 Study Comparing Two Oral Tablet Formulations of a CGRP Receptor Antagonist in Healthy Adults Randomized, Single Dose, Crossover Design under Fasting Conditions

What this Trial Is About

Researchers are evaluating the bioequivalence of two different oral disintegrating tablet ODT formulations of a CGRP receptor antagonist in healthy adult participants who are fasting. This Phase 1, open-label, randomized crossover study aims to compare the blood levels of the alternative ODT formulation ODT2 with the approved ODT formulation to understand how similarly they are absorbed and processed in the body. Participants will receive single doses of both the test formulation ODT2 and the reference approved formulation, administered on top of the tongue under fasting conditions. The study uses a crossover design where participants receive one formulation followed by the other in randomized sequences. No blinding is involved, and the study is conducted by Pfizer. During the study, participants will be monitored for plasma drug concentrations over 72 hours to measure key pharmacokinetic outcomes such as the area under the plasma concentration-time curve and maximum plasma concentration. Safety will be assessed by recording any treatment-emergent adverse events up to 36 days after the last dose. Overall, participants will be involved in medical evaluations, laboratory tests, and ECGs to ensure health and monitor effects throughout the study.

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