NL-OMON49458已完成不适用
A phase 1, open-label, randomized, 2-period, 2-sequence, crossover study to evaluate the bioequivalence of Bosutinib pediatric capsule and the commercial tablet formulations in healthy participants under fed condition - Bioequivalence of Bosutinib Capsule Relative to Tablet
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer, Inc.
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Female participants of non-childbearing potential and/or male participants
- •must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
- •2. Male and female participants who are overtly healthy as determined by
- •medical evaluation including a detailed medical history, complete physical
- •examination, vital signs which include BP and pulse rate measurement, clinical
- •laboratory tests, and ECG.
- •3. Participants who are willing and able to comply with all scheduled visits,
- •treatment plan, laboratory tests, lifestyle considerations, and other study
- •procedures.
- •4. BMI of 17.5 to 30.0 kg/m2; and a total body weight >50 kg (110 lb).
- •5. Capable of giving signed informed consent as described in Appendix 1, which
- •includes compliance with the requirements and restrictions listed in the ICD
- •and in this protocol.
排除标准
- •1. Evidence or history of clinically significant hematological, renal,
- •endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
- •neurological, dermatological, or allergic disease (including drug allergies,
- •but excluding untreated, asymptomatic, seasonal allergies at the time of
- •2. Any condition possibly affecting drug absorption (eg, gastrectomy,
- •cholecystectomy).
- •3. History of HIV infection, hepatitis B, or hepatitis C; positive testing for
- •HIV, HBsAg, HBcAb or HCVAb. As an exception, a positive HBsAb as a result of
- •participant vaccination is permissible.
- •4. Other medical or psychiatric condition including recent (within the past
- •year) or active suicidal ideation/behavior or laboratory abnormality that may
- •increase the risk
- •PF-05208763 of study participation or, in the investigator*s judgment, make the
- •participant inappropriate for the study.
- •5. A history of hypersensitivity to the active compounds or to any inactive
- •ingredients (excipients) contained in the formulations.
- •For complete overview see the protocol
研究者
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