Clinical trial NCT01183390: Anastrozole 1 mg Tablets Under Fed Conditions
Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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 fed conditions.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years of age or older.
* Body mass index between 18 and 30, inclusive.
* Indicate non-child bearing status by one of the following criteria:

  * Indication of successful hysterectomy.
  * No spontaneous menses for at least 1 year, must have luteinizing hormone (LH) and follicle stimulation hormone (FSH) levels within the postmenopausal range.
  * Indication of successful bilateral oophorectomy.
* Negative for:

  * HIV.
  * Hepatitis B surface antigen and Hepatitis C antibody.
  * Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, and methadone).
  * Urine cotinine test.
  * Serum pregnancy test.
* 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 or presence of:

  * Hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity.
  * Alcoholism within the past 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine containing products within the last 6 months.
* 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.

Primary outcomes:
measure: Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
timeFrame: Blood samples collected over a 72 hour period.
measure: AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
timeFrame: Blood samples collected over a 72 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Pharma Medica Research Inc.
state: Ontario
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu (Eric) Chen, M.D., Ph.D., FRCP
role: PRINCIPAL_INVESTIGATOR
References: