Estrogen deficiency: vasoconstrictive diseases (hot flashes), reproductive and urinary tract nutritional diseases (vulvovaginal atrophy, difficulty in sexual intercourse, urinary incontinence), and psychiatric diseases (sleep disorders, weakness).
Conditions
Interventions
Group A:Fasting condition: the test formulation was given in the first period, and reference formulation was given in the second period
Group B:Fasting condition: the reference formulation was given in the first period, and test formulation was given in the second period
Group C:Fed condition: the test formulation was given in the first period, and reference formulation was given in the second period
Group D:Fed condition: the reference formulation was given in the first period, and test formulation was given in the second period
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be included in this trial: 1)Healthy menopausal female subjects aged 45 to 65 (including 45 and 65 years old). 2) The weight of the subject shall not be less than 45 kg; Body mass index (BMI)=weight (kg)/height 2 (m2), with a body mass index within the range of 18-28 (including critical values). 3) More than 12 months from the last menstrual period. 4) The thickness of the endometrium is less than 5 mm. 5) FSH>40 IU/l,E2<110 pmol/l. 6) According to the previous medical history, comprehensive physical examination and specified laboratory tests, the researcher determined that the subject was healthy. 7) Before the experiment, sign an informed consent form and have a thorough understanding of the experiment content, process, and potential adverse reactions. 8) Able to complete the experiment according to the protocol requirements.
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria will be excluded: 1) Abnormal physical examination, electrocardiogram, laboratory examination, abdominal B-ultrasound, vital signs and test related examinations (clinically significant as judged by the researcher) 2) Any disease that has been or is currently suffering from major diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, and the researcher believes may interfere with the test results or pose potential hazards to volunteers participating in the test; 3) Have a history of allergies to drugs, two or more foods, or other substances; 4) Have a history of breast cancer, endometrial cancer or other known or suspected estrogen dependent tumors; 5) Those with a history of deep vein thrombosis/other thrombosis; 6) Gynecological B-ultrasound indicates uterine fibroids or submucosal fibroids larger than 2cm, adenomyosis, endometrial polyps, or ovarian tumors; 7) Those who have taken any medication (including Chinese herbal medicine) and health products within 2 weeks before the experiment; 8) Those who use long-term estrogen or progesterone injections or implants within 6 months before the experiment; 9) Within 8 weeks before the trial, those who received oral estrogen and/or oral or intrauterine progesterone treatment; 10) Those who use vaginal hormone products (ring, cream, gel) within 1 week before the test; 11) Those who have been vaccinated within one week before the trial or those who have been vaccinated during the planned trial period; 12) Those taking thyroid hormone replacement therapy; 13) Those who participated in any clinical trial within 3 months prior to the trial; 14) Individuals who underwent surgery within 6 months before the trial; 15) Individuals who have donated blood, or have lost a large amount of blood (>450 ml) within 3 months before this study; 16) Alcoholics or those who frequently drink alcohol within the 6 months prior to the experiment, i.e. drinking more than 2 units of alcohol per day (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); Or positive for alcohol breath test; 17) Drug abusers or drug users; Positive results from drug screening (morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinoid acid); 18) Individuals who smoke more than 5 cigarettes per day within the first 3 months of the experiment, or those who are positive for nicotine screening; 19) Drinking excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day; 20) Those who are unwilling to stop drinking alcohol or any alcoholic products, tea, coffee and/or caffeinated drinks, bean products or honey products, foods rich in xanthine (such as sardine, animal livers, etc.), have special requirements for diet and cannot follow the unified diet during the test; 21) Those who consume or plan to consume grapefruit or grapefruit related citrus fruits (such as lime, grapefruit), carambola, papaya, pomegranate, or other fruit products within 3 days before the first administration of the study drug; 22) Those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungals, HIV protease inhibitor, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;?z;adverse event; | — |
Countries
China
Contacts
Public ContactFan Lian-Lian
Deyang People's Hospital
Outcome results
None listed