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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат ODT2 Test formulation
  Test Formulation
• Препарат ODT Reference formulation
  Reference Formulation

Первичные конечные точки

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations [Срок оценки: 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 [Срок оценки: Pre-dose to 72 hours]
• Maximum observed plasma concentration (Cmax) of test and reference formulations [Срок оценки: Pre-dose to 72 hours]

Вторичные конечные точки (1)

• Number of participants with treatment emergent adverse events (TEAEs) [Срок оценки: From baseline up to 36 days after last dose of study intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Бельгия · 1 центр

• Pfizer Clinical Research Unit - Brussels — Brussels

Идентификаторы

NCT: NCT07594769 · C4951092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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