NCT07594769CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 12 May 2026
- Start date
- 11 May 2026
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT07594769
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 11 May 2026 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Lab values
- 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.
Other
- Unwilling or unable to comply with the Lifestyle Considerations criteria of this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.