IRCT20180620040164N66尚未招募Unknown
Bioequivalence study of ?Lansoprazole 30 mg Capsule of Dorsa Pharmaceutical Co. and Agopton of Takeda as reference in 24 healthy male under fasting.
Dorsa Pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
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 years 至 45 years（—）
- 性别
- Male
入选标准
- •Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
- •Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
- •Subjects with normal vital signs.
- •Subjects who agree with patient consent form.
排除标准
- •History of known sensitivity to the tested product
- •History of specific disease or unusual values ??in laboratory tests and general clinical examination
- •Hypertension (blood pressure in a standing position and after at least 5 minutes of rest, systole greater than or equal to 140 mmHg and diastole greater than or equal to 90 mmHg)
- •Smoking more than 10 cigarettes a day
- •Loss of more than 500 ml of blood in less than 7 days.
研究者
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