Randomized, open-label, two-treatment, two-cycle, crossover design bioequivalence study of a single oral dose of dienogest tablets in healthy subjects under fed conditions

INTERVENTION: 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; CONDITION: Endometriosis PRIMARY OUTCOME: Cmax;Tmax;AUC0‐t;AUC0‐8;?z;t1/2;F; 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 inde Xwas in the range of 19 to 26 kg/m2 (inclusive). Body mass inde X(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 cyc