Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition

• Status: Recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fasted conditions to assess the bioequivalence between two formulations of Anastrozole.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Anastrozole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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;