NL-OMON44321已完成不适用
A COMPARATIVE, OPEN-LABEL, RANDOMIZED, 2 PERIODS, 2 SEQUENCES CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUSPENSION (FT218) FORMULATION (SINGLE DOSE ADMINISTERED AT THE DOSE OF 6 G) VERSUS THE MARKETED REFERENCE XYREM® (AT THE DOSE OF 2*3 G) IN HEALTHY VOLUNTEERS - FT218 Bioavailability versus Xyrem®
Flamel Ireland Limited (Ltd) trading under the business name Avadel Ireland0 个研究点目标入组 28 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
- 28
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 or female (Caucasian)
- •age 18 - 55 years, including
- •(BMI) 18.0 - 28.0 kilograms/meter2
- •weight at least 60 kg
- •not smoking
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
研究者
相似试验
进行中（未招募）
1 期
A study to compare the absorption into the body of the drug sodium oxybate in FT218 in comparison to the currently marketed product Xyrem®.A trial on healthy volunteer fore the development of a treatment for cataplexy and excessive daytime sleepiness in narcolepsy.MedDRA version: 20.0 Level: LLT Classification code 10007738 Term: Cataplexy and narcolepsy System Organ Class: 100000004852EUCTR2016-004342-28-NLFlamel Ireland Ltd trading under the business name Avadel Ireland24
已完成
1 期
BE STUDY OF AVOMINE MOUTH DISSOLVING TABLET IN HEALTHY HUMAN MALE SUBJECTSCTRI/2018/06/014352Abbott Healthcare Private Limited32
已完成
不适用
A clinical trial to study the pharmacokinetic comparision of two formulations of Docetaxel injections in Advanced Solid Tumor PatientsCTRI/2009/091/000316Intas Pharmaceuticals Limited India32
已完成
不适用
Pharmacokinetic study of two formulations of Azathioprine Tablets 50 mg in Adult Subjects with Rheumatoid Arthritis.CTRI/2018/07/014995Alkem Laboratories Ltd64
招募中
Unknown
To assess blood concentration of Olaparib Tablets 150 mg at different times in patients with Cancer following Multiple-doseCTRI/2023/04/051731Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited)