Status:
UNKNOWN
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fed conditions to assess the bioequivalence between two formulations of Anastrozo...
Detailed Description
Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formula...
Eligibility Criteria
Inclusion
- Healthy Postmenopausal volunteers aged between 18 and 65 years old.
- The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.
- The subjects have no family planning within 6 months and could select contraceptive method.
- Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.
Exclusion
- Meet the diagnostic criteria for osteoporosis.
- Subjects with vaginal bleeding.
- blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
- any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.
- any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
- smoking more than 5 cigarettes per day during the 3 months prior to screening;
Key Trial Info
Start Date :
July 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04445922
Start Date
July 4 2020
End Date
October 30 2020
Last Update
June 30 2020
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003