bioavailability study in healthy postmenopausal women
Conditions
Interventions
Group 1:Single dose for test product (Letrozole 2.5mg, Fresenius Kabi Oncology Ltd.) will be administered in period?as well as single dose for reference product (Letrozole 2.5mg, Femara, Novartis Phar
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, Freseniu
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Chinese healthy postmenopausal women older than 40 years age; 2. Body Mass Index (BMI) between 18 and 25 (inclusive), calculated as weight (kg) / height (m)2, and weight at least 50 Kg; 3. Menopause at least one year, and test the plasma FSH and estradiol level to ensure the menopausal state; 4. No significant diseases or clinically significant abnormal findings, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings found during sceening period; 5. Able to comply with the study procedures, decided by principal investigator; 6. Obtain written consent for participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Allergic, hypersensitive or with idiosyncratic reaction to letrozole or any excipient in the study and reference drug or any drug; 2. With any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other systems; 3. Ingestion of any medicine at any time in 14 days before dosing in Period-I; 4. The history of using drug which can damage main organs in the past 3 months; 5. The history of asthma; 6. A recent history of alcoholism more than 28 units (1 unit = 285ml of beer or spirits or a glass of wine 25ml) or consumption of alcohol within 48 hours prior to receiving the study medicine; 7. Smokers; 8. The presence of clinically significant abnormal laboratory values during screening; 9. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scan; 10. History of psychiatric disorders; 11. With history of difficulty with donating blood; 12. Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine; Note: In case the blood loss is <=200 mL; subject may be enrolled 60 days after blood donation; 13. A positive hepatitis screen including hepatitis B surface antigen and anti-HCV antibodies; 14. A positive test result for HIV antibody and/or syphilis; 15. The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Letrozole concentration in plasma; | — |
Countries
China
Contacts
Public ContactMingcheng WAN
Outcome results
None listed