NCT01277991
已完成
1 期
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions
概览
- 阶段
- 1 期
- 干预措施
- Treatment A
- 疾病 / 适应症
- Arthritis, Rheumatoid
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PK parameters: AUCinf, AUClast and Cmax of CP-690,550
- 状态
- 已完成
- 最后更新
- 15年前
概览
简要总结
In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .
详细描述
This is a bioequivalence study for CP-690,550.
研究者
入排标准
入选标准
- •Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
- •No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
排除标准
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.
- •Evidence or history of any clinically significant infections within the past 3 months.
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
研究组 & 干预措施
Sequence 2
干预措施: Treatment A
Sequence 2
干预措施: Treatment B
Sequence 1
干预措施: Treatment A
Sequence 1
干预措施: Treatment B
结局指标
主要结局
PK parameters: AUCinf, AUClast and Cmax of CP-690,550
时间窗: PK blood samples out to 24 hours post dose in each period
次要结局
- Safety: vital signs(Prior to dosing in each period and at 24 hours post last dose in Period 2)
- PK parameters: Tmax, AUCt and half-life of CP-690,550(Derived from PK blood samples out to 24 hours post dose in each period)
- Safety: laboratory tests(Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period)
- Safety: adverse event reporting(Throughout study)
研究点 (1)
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