JPRN-jRCT1080224760已完成1 期
A Bioequivalence Study of CS-3150 - Evaluation of bioequivalence between esaxerenone 5 mg tablet and esaxerenone 5 mg OD tablet (CS-3150 OD tablet) in healthy Japanese subjects
DAIICHI SANKYO Co.,Ltd0 个研究点目标入组 48 人开始时间: 2019年7月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
The two-sided 90% confidence intervals for the ratios of geometric LS means for the bioequivalence parameters Cmax and AUClast fell within predefined the bioequivalence range of 0.80 to 1.25 in both Study 1 (with water) and Study 2 (without water). Therefore, the test formulation was judged to be bioequivalent to the reference formulation. There were no obvious differences in safety after single oral administration of 5-mg esaxerenone or 5-mg CS-3150 ODT, and no new safety concerns were observed.
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
- •- Aged >= 20 years and <= 45 years at the time of informed consent
- •- BMI of >= 18.5 kg/m2 and < 25.0 kg/m2 at screening
- •- Sitting systolic BP < 140 mmHg and diastolic BP < 90 mmHg at screening
- •- Pulse rate <= 99 bpm at screening
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
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