Pharmacokinetics Study of Qing'E Pill

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Menopause

Intervention / Treatment
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* Drug: Qing'E pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 15. 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qing'E pill<br>Administered twice a day, and each 9 g | Drug: Qing'E pill<br>* Qing'E pill is composed of eucommia, psoralen, walnuts and garlic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC)) | To detect the main components of Qing'E pill into the blood such as psoralen and Isopsoralen. | Up to 48 hours postdose for each period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, pharmacokinetic