Pharmacokinetics Study of Qing'E Pill

NCT01931436 | Completed Phase 1 DMC

• 1 other identifier: QE-2458-2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Menopause, pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Qing'E pill

EXPERIMENTAL

Administered twice a day, and each 9 g

Drug: Qing'E pill

Interventions

Qing'E pill DRUG

Qing'E pill is composed of eucommia, psoralen, walnuts and garlic.

Qing'E pill

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Wuxi People's Hospital: collaborator

Study Sites (1)

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 210038, China

Location

MeSH Terms

Interventions

Qing'e pill

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

CN (1)