bioavailability study in healthy postmenopausal women
Conditions
Interventions
Group 1:Single dose for test product (Letrozole 2.5mg, Shandong New Times Pharmaceutical Co., Ltd.) will be administered in period?as well as single dose for reference product (Letrozole 2.5mg, Femara
Group 2:Single dose for reference product (Letrozole 2.5mg, Fema ra, Novartis Pharmaceutical Company.) will be administered in period?as well as single dose for test product (Letrozole 2.5mg, Shandong
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily participate and sign the informed consent form and the process of obtaining the informed consent form conforms to GCP regulations; 2) Women of no reproductive potential (menopausal or surgical infertility). Those who meet any of the following can be considered to have reached the menopausal state: a) After bilateral oophorectomy, estradiol (E2) 30mIU/mL. b) Natural menopause for =12 months, estradiol (E2) 30mIU/mL without chemotherapy or drug-induced ovarian castration within the past year; 3) Age 18~65 years old, including critical values; 4) Weight =45.0kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI ranged from 19.0 to 28.0 kg/m2, including critical values.
Exclusion criteria
Exclusion criteria: 1) Physical examination, vital signs, laboratory examinations, electrocardiogram examination, four items of blood transfusion, coagulation function and other abnormalities with clinical significance; 2) Those who have major medical history of heart, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, respiratory, neurological or psychiatric diseases in the past 2 years, or those who currently have the above system diseases; 3) Those who have a history of drug abuse or a positive drug screening test in the past 5 years; 4) Those who have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, food or pollen), or known to be allergic to the components of this medicine* (such as lactose intolerance) ) or similar allergy; *The main ingredients of the test preparation: letrozole, excipients: lactose FlowLac 100, corn starch, microcrystalline cellulose M102, sodium starch glycolate, silicon dioxide, magnesium stearate, film coating pre- Mixture (stomach-soluble type); reference preparation main ingredients: letrozole, excipients: colloidal silicon dioxide, iron oxide, hypromellose, lactose, magnesium stearate, corn starch, microcrystalline cellulose, Polyethylene glycol, sodium starch glycolate, talc, titanium dioxide; 5) Patients with esophageal reflux, gastric bleeding or peptic ulcer disease within 6 months before the trial, heartburn more than once a week, or any surgical operation (such as cholecystectomy) that may affect drug absorption; 6) Those who have used the vaccine for less than 1 month before screening (less than 1 month after the injection of the new coronavirus adenovirus vector vaccine, and less than 2 weeks after the injection of the inactivated and recombinant protein vaccine); 7) Positive alcohol breath test results, or alcoholics within the past 3 months (drinking more than 14 units of alcohol per week: 1 unit = about 285mL of beer, or about 25mL of spirits, or about 100mL of wine), or unable to drink throughout the test period give up drinking; 8) Those who smoked =5 cigarettes per day within 3 months before screening or those who could not give up smoking during the whole trial period; 9) Those who drank excessive tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 250mL) within 3 months before screening, or ingested any caffeine or caffeine within 48 hours before the first dose of the study. Food or drink with grapefruit juice (such as coffee, strong tea, chocolate, cola, grapefruit, etc.); 10) Those who cannot follow a unified diet (such as intolerance to standard meals, etc.) or have difficulty swallowing; 11) Difficulty in collecting blood or fainting of needles, fainting of blood or intolerance of venipuncture; 12) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health products within 14 days before screening; 13) Use of any drugs that inhibit or induce liver metabolism of drugs in the 28 days before screening (eg: inducersbarbiturates, rifampicin, St. Johns wort, carbamazepine, phenytoin, glucocorticoids, omeprazole azoles; inhibitorsincluding but not limited to ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin); 14) Those who have participated in other clinical trials within 3 months before screening; 15) Those who donate blood or lose blood due to other reasons = 400mL within 3 months bef
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Letrozole concentration in plasma;Cmax;AUC0-72h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z; | — |
Countries
China
Contacts
Public ContactWei Zhang
Outcome results
None listed