JPRN-jRCT1080223737已完成1 期
A Bioequivalence study of DS-5058b (immediate-release tablet) and oxycodone hydrochloride hydrate in healthy Japanese subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
研究概览
简要总结
The ratio of geometric least-square means and 90% CI for Cmax and AUCall were within the bioequivalence criteria (0.80-1.25). DS-5058b (immediate-release tablet) was judged to be bioequivalent to the reference drug. - There was no meaningful difference in TEAE between 5 mg DS-5058b (immediate-release tablet) and reference drug, and no safety concern was noted in single oral administration of both drugs.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •Japanese male
- •- Between the age of 20 and 45
- •- Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2
排除标准
- •- Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy)
- •- People with drug or alcohol dependence. etc
研究者
相似试验
已完成
1 期
DS-5058b (extended-release tablet) bioequivalence studyHealthy volunteersJPRN-jRCT1080223420DAIICHI SANKYO Co.,Ltd.48
已完成
1 期
A Bioequivalence Study of CS-3150 (esaxerenone) OD tabletHealthy VolunteersJPRN-jRCT1080224760DAIICHI SANKYO Co.,Ltd48
已完成
1 期
Bioequivalence Study of a Generic Sitagliptin Phosphate Tablet 100 mgHealthy subjectsbioequivalence studySitagliptinTCTR20220621004Duopharma Biotech Berhad27
已完成
1 期
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male SubjectsHealthy VolunteersNCT01861626Pierre Fabre Dermatology45
已完成
1 期
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-RApetite StimulantsNCT06147908Daewon Pharmaceutical Co., Ltd.54