Endometriosis
Conditions
Interventions
Test preparation-Reference preparation group:cycle 1 the test product was taken orally
cycle 2 reference preparation was taken orally
Reference preparation- Test preparation group:cycle 1 reference preparation was taken orally
cycle 2 the test product was taken orally
Sponsors
affiliated secondary hospital of Liaoning traditional Chinese medicine university
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1)Subjects are fully informed of the purpose of the trial, its content, procedure, and possible adverse effects, volunteered as subjects, and signed an informed consent form prior to the start of any procedure. 2)Healthy female subjects aged 18-45 years old (inclusive). 3)Subjects should weigh no less than 45 kg. Body mass index was in the range of 19 to 26 kg/m2 (inclusive). Body mass index (BMI) = weight (kg)/height2 (m2). 4)Vital signs, physical examination (skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, bones/muscles, nervous system, etc.), 12-lead electrocardiogram, gynecologic ultrasound (routine color ultrasound of gynecologic organs), laboratory tests (including routine blood, blood biochemistry, blood pregnancy, coagulation function, routine urine, immune tetralogy) with normal test results or those judged by the clinician to be abnormal without clinical significance. 5)Subjects must have regular menstruation (menstrual cycle of 21 to 35 days and days of menstruation of 3 to 7 days). 6)Subjects are able to communicate well with the investigator and understand and comply with the requirements of this trial.
Exclusion criteria
Exclusion criteria: 1)Subjects with a history of any clinically serious disease of the hematological system, circulatory system (especially severe arterial disease, diabetes combined with vascular damage, venous thromboembolism or thrombosis-like disease), digestive system, urinary system, respiratory system, nervous system (especially depression or insomnia), immune system, endocrine system, malignancy, psychiatric abnormalities and metabolic abnormalities, or any other disease or physiological condition that may interfere with the test results. 2)Allergy or food or drug allergy (especially to dienogest and its excipients or other progestin-like drugs). 3)Those with a history of needle phobia and blood phobia, those who cannot tolerate blood collection with intravenous indwelling needles, those who have difficulty collecting blood from a vein, or those with known severe bleeding tendencies. 4)Those who have difficulty swallowing or have special dietary requirements and cannot comply with the uniform diet (e.g. intolerance to standard meal foods, lactose intolerance, etc.) and the corresponding regulations. 5)Those who have undergone surgery within 3 months prior to the trial or are scheduled to undergo surgery during the trial, and those who have undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug. 6)History of substance abuse (including use of prohibited substances banned for medical use and drugs listed for control) within 2 years prior to the trial or drug use within 3 months prior to the trial 7)Those who have taken any prescription drugs, over-the-counter drugs, and any health food (e.g., functional vitamins) or herbal products within 30 days prior to the test drug. 8)Those who have taken the test drug, or participated in any clinical trial as a subject within 3 months prior to the trial 9)Those who have donated or lost more than 200 mL of blood in the 3 months prior to the trial, or those who plan to receive blood transfusion or use blood products during the trial. 10)Those who have received live or live attenuated vaccine within 1 month prior to the trial, or who plan to receive live or live attenuated vaccine during the trial. 11)Those who smoked more than 5 cigarettes per day on average during the 3 months prior to the trial, or who could not guarantee abstinence from smoking during the trial. 12)Regular drinkers in the 3 months prior to the trial, i.e. more than 2 units of alcohol per day on average (1 unit = 360 mL of beer or 45 mL of spirits with 40 % alcohol or 150 mL of wine with 12 % alcohol), or those who could not stop drinking during the trial. 13)Those who cannot stop consuming fruits that affect metabolic enzymes (e.g. grapefruit, pomelo, dragon fruit, lime, carambola, mango, etc.) or related products 7 days prior to and during the trial drug administration. 14)Those who cannot stop consuming any food or beverage containing caffeine or xanthine (e.g. coffee, strong tea, cola, chocolate, animal liver, etc.) 48 hours prior to the drug administration and during the trial. 15)Women who are menstruating, pregnant or breastfeeding, or who have had unprotected sex within the last 2 weeks, or who have used a form of contraception containing hormones within 1 month prior to the trial; who are planning to have children or donate eggs throughout the trial or within 6 months after the end of the study, who are unwilling to use one or more physical contraceptives during the trial and wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-8;?z;t1/2;F; | — |
Countries
China
Contacts
Public ContactChunyan Zhao
affiliated secondary hospital of Liaoning traditional Chinese medicine university
Outcome results
None listed