NL-OMON34811已完成不适用
A phase I, open-label, randomized, three-way cross-over study to determine the relative bioavailability of an oral capsule formulation, given both in the fasted state and after a high fat meal, compared to an oral suspension of PSN821 in healthy male volunteers. - PSN821 3-way cross-over relative bioavailability study.
OSI Pharmaceuticals0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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
- •* healthy male
- •* between 18 * 55 years of age
- •* BMI is between 18 * 25 kg/m2
- •* at screening the state of health must satisfy the entry requirements
排除标准
- •* suffering from severe illness such as hepatitis B, hepatitis C or HIV
- •* taken part in more than 3 other drug studies in the 10 months prior to the start of this study
- •* donated blood within the 60 days prior to the start of this study (50 mL or more)
- •* donated more than 1.5 liters during the 10 months prior to the start of this study
研究者
相似试验
已完成
不适用
A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjectsNon-alcoholic steatohepatitisNL-OMON49206Poxel SA12
已完成
1 期
A Phase I, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of EMA401 Sodium Salt When Administered Orally in Fed (high fat meal or orange juice only) and Fasted Healthy Adult Males.Neurological - Other neurological disordersPostherpetic NeuralgiaACTRN12610000798066Spinifex Pharmaceuticals Pty Ltd15
进行中(未招募)
不适用
AMulti-drug resistant tuberculosisMedDRA version: 14.1Level: PTClassification code 10044755Term: TuberculosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-005492-13-NLJanssen infectious diseases BVBA
已完成
不适用
A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatric formulations using a 100 mg tablet formulation as the reference, with and without food.10004018tuberculosisNL-OMON38686Janssen Infectious Diseases BVBA36
已完成
1 期
A Phase 1, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of Capsule and Tablet Dosage Forms of EMA401 Sodium Salt When Administered Orally in Healthy Adult MalesACTRN12615000074594Spinifex Pharmaceuticals Pty Ltd15
