NCT01931436已完成1 期
A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics of the Main Components of Qing'E Pill (a Chinese Medicine Formula) Into the Blood in Chinese Menopausal Women
Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
研究概览
简要总结
This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as psoralen and Isopsoralen will be detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
- •Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
- •The score of Kupperman index is not less than
- •Patients unused estrogen tablets or progesterone injection in 6 months.
- •Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
- •Get subjects informed consent process should comply with GCP requirements.
排除标准
- •There is no clinical significance abnormal in physical and laboratory examination.
- •Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
- •Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g/L).
- •Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
- •Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
- •People with allergies.
- •People taking other drugs within 14 days before the trail.
- •Patients are participating in other clinical trials within 3 months.
- •Pregnant Women.
- •Alcoholics or smokers (past or smoking).
研究组 & 干预措施
Qing'E pill
Experimental
Administered twice a day, and each 9 g
干预措施: Qing'E pill (Drug)
结局指标
主要结局
Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
时间窗: Up to 48 hours postdose for each period
To detect the main components of Qing'E pill into the blood such as psoralen and Isopsoralen.
次要结局
未报告次要终点
研究者
研究点 (1)
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