Migraine
Conditions
Brief 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.
Detailed description
To evaluate the bioequivalence of ODT2 (Test) versus approved ODT (Reference) formulations administered on top of the tongue in healthy adult participants under fasting conditions.
Interventions
DRUGODT2 Test formulation
Test Formulation
DRUGODT Reference formulation
Reference Formulation
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Have a body mass index (BMI) of 16-32 kg/m2, and a body weight \>45 kg.
Exclusion criteria
1. 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). 2. 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. 3. 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. 4. 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. 5. A positive urine drug test. A single repeat for positive drug screen may be allowed. 6. Unwilling or unable to comply with the Lifestyle Considerations criteria of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations | Pre-dose to 72 hours |
| Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) of the test and reference formulations | Pre-dose to 72 hours |
| Maximum observed plasma concentration (Cmax) of test and reference formulations | Pre-dose to 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | From baseline up to 36 days after last dose of study intervention |
Countries
Belgium
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed