Pharmacokinetics Study of Qing'E Pill

Phase 1

Completed

• Conditions: Menopause
• Interventions: Drug: Qing'E pill

• Registration Number: NCT01931436
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
2. Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
3. The score of Kupperman index is not less than 15.
4. Patients unused estrogen tablets or progesterone injection in 6 months.
5. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
6. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria

1. There is no clinical significance abnormal in physical and laboratory examination.
2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
3. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g/L).
4. 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.
5. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
6. People with allergies.
7. People taking other drugs within 14 days before the trail.
8. Patients are participating in other clinical trials within 3 months.
9. Pregnant Women.
10. Alcoholics or smokers (past or smoking).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Qing'E pill	Qing'E pill	Administered twice a day, and each 9 g

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))	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.

Trial Locations

Locations (1)

Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China