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The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.
Full description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
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Inclusion criteria
Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years or age or older.
Body mass index (BMI) between 19 and 30, inclusive.
Indicate non-child bearing status by one of the following criteria:
Negative for:
No significant diseases or clinically significant findings in a physical examination.
No clinically significant abnormal laboratory values.
No clinically significant findings in the 12-lead electrocardiogram (ECG).
No clinically significant findings from the vital signs measurement.
Be informed of the nature of the study and given written consent prior to receiving any study procedure.
Participants in this study will be unable to have children (i.e. post-menopausal, hysterectomy).
Exclusion criteria
Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
Known history of:
Taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
Taken any hormone replacement therapy (HRT) for 4 weeks prior to dosing.
On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
Donated up to 250 mL of blood within the previous 30 days OR donated from 251 to 500 mL of blood in the previous 45 days OR donated more than 500 mL of blood in the previous 56 days.
Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
Difficulty fasting or consuming the standard meals.
Do not tolerate venipuncture.
Unable to read or sign the informed consent form.
22 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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