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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve from time zero extraploated to infinite time (AUCinf) of the test and reference formulations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment Sequence 1
干预措施: ODT2 Test formulation (Drug)
Treatment Sequence 2
干预措施: ODT2 Test formulation (Drug)
Treatment Sequence 2
干预措施: ODT Reference formulation (Drug)
Treatment Sequence 1
干预措施: ODT Reference formulation (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero extraploated to infinite time (AUCinf) of the test and reference formulations
时间窗: 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
时间窗: Pre-dose to 72 hours
Maximum observed plasma concentration (Cmax) of test and reference formulations
时间窗: Pre-dose to 72 hours
次要结局
- Number of participants with treatment emergent adverse events (TEAEs)(From baseline up to 36 days after last dose of study intervention)