Overview

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;