CompletedNCT01182181Updated Nov 15, 2010Results posted

Anastrozole 1 mg Tablets Under Fasting Conditions

A Phase 1 interventional study of Anastrozole (Teva Pharmaceuticals USA) and Anastrozole (Arimidex®) in Healthy, sponsored by Teva Pharmaceuticals USA. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-15.

Sponsored by Teva Pharmaceuticals USA · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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 fasting conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions studied

Healthy

Keywords

Healthy Subjects
Bioequivalence

In context

Lead sponsor

Teva Pharmaceuticals USA is the lead sponsor of 171 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes

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:
- Indication of successful hysterectomy.
- No spontaneous menses for at least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels within 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

Exclusion Criteria:

Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
Known history of:
- Hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity.
- Alcoholism within the last 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.

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 22 participants (actual)

Study arms

Experimental
Investigational Test Product
Anastrozole Tablets, 1 mg
Drug: Anastrozole (Teva Pharmaceuticals USA)
Active comparator
Reference Listed Drug
Arimidex® Tablets, 1 mg
Drug: Anastrozole (Arimidex®)

Interventions

DrugAnastrozole (Teva Pharmaceuticals USA)
1 mg Tablets
DrugAnastrozole (Arimidex®)
1 mg Tablets
Also known as: Arimidex®

What researchers measure

Primary outcomes

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Anastrozole Cmax.
Time frame: Blood samples collected over a 72 hour period.
AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Anastrozole AUC0-t.
Time frame: Blood samples collected over a 72 hour period.

Results

Posted Nov 15, 2010

Participant flow

First Intervention

Participant flow — First Intervention
Milestone	Anastrazole (Test) First	Arimidex® (Reference) First
Started	11	11
Completed	10	11
Not completed	1	0
Withdrew: Adverse event	1	0

Washout of 21 Days

Participant flow — Washout of 21 Days
Milestone	Anastrazole (Test) First	Arimidex® (Reference) First
Started	10	11
Completed	10	10
Not completed	0	1
Withdrew: Withdrawal by subject	0	1

Second Intervention

Participant flow — Second Intervention
Milestone	Anastrazole (Test) First	Arimidex® (Reference) First
Started	10	10
Completed	10	10
Not completed	0	0

Outcome measures

PrimaryCmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Anastrozole Cmax.

Time frame:: Blood samples collected over a 72 hour period.
Reported as:: Mean · ng/mL

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
ng/mL	Anastrazole (Test)	Arimidex® (Reference)
Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)	17.1 ± 3.3	17.8 ± 2.7

Statistical analysis

Anastrazole (Test) vs Arimidex® (Reference) · Ratio of the t/r geometric mean x 100: 95.6 · 90% CI 92.34 to 98.95Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

PrimaryAUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Anastrozole AUC0-t.

Time frame:: Blood samples collected over a 72 hour period.
Reported as:: Mean · ng*h/mL

AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
ng*h/mL	Anastrazole (Test)	Arimidex® (Reference)
AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	503 ± 110	519 ± 94

Statistical analysis

Anastrazole (Test) vs Arimidex® (Reference) · Ratio of the t/r geometric mean x 100: 96.3 · 90% CI 93.14 to 99.57Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

Adverse events

Collected over Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Anastrazole (Test)	—	0/22 (0%)	2/22 (9.1%)
Arimidex® (Reference)	—	0/22 (0%)	4/22 (18.2%)

Most frequent other events

Most frequent other events
Event	Anastrazole (Test)	Arimidex® (Reference)
HematuriaGeneral disorders	2/22	1/22
Abnormal UrineGeneral disorders	2/22	1/22
HeadacheGeneral disorders	0/22	2/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Anastrazole (Test) First	Arimidex® (Reference) First	Total
<=18 years	0	0	0
Between 18 and 65 years	10	11	21
>=65 years	1	0	1

Sex: Female, Male
Sex: Female, Male(Participants)	Anastrazole (Test) First	Arimidex® (Reference) First	Total
Female	11	11	22
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Anastrazole (Test) First	Arimidex® (Reference) First	Total
Caucasian	10	11	21
Black	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Anastrazole (Test) First	Arimidex® (Reference) First	Total
Canada	11	11	22

Study locations

1 site

Pharma Medica Research Inc.
Toronto, Ontario M1R 5A3, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01182181
Lead sponsor: Teva Pharmaceuticals USA
First posted: Aug 16, 2010
Start date: Aug 2005
Primary completion: Sep 2005
Completion: Sep 2005
Results posted: Nov 15, 2010
Last update: Nov 15, 2010

Study contacts

Xueyu (Eric) Chen, M.D., Ph.D., FRCP

principal investigator · Pharma Medica Research, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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