Overview

Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fasting Conditions

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Anastrozole
Criteria
Inclusion Criteria:

1. The subjects should be postmenopausal healthy women who have attained complete
menopause naturally or surgically and have not had menstruation for at least one year
and are not on hormone replacement therapy.

2. The subjects should have Estradiol level ≤ 20 pg/ml & serum follicular stimulating
hormone (FSH) level ≥ 50 mlU/ml during the screening.

3. The subjects should be screened within 21 days prior to the administration of first
dose of the study drug.

4. The subjects should have a BMI between 18.5 to 26.4 (30-39 years), 18.5 to 27.8 (40-49
years), 18.5 to 28.4 (50-59 years) & 18.5 to 27.5 (60-69 years) weight in kg/ height2
in meter.

5. The subjects should be able to communicate effectively with study personnel.

6. The subjects should be able to give written informed consent to participate in the
study.

Exclusion Criteria:

1. The subjects who have a history of allergic responses to Anastrozole or other related
drugs.

2. The subjects who are using female hormone replacement therapies, thyroid hormone
replacement therapies, or antihypertensive therapies.

3. The subjects who have significant diseases or clinically significant abnormal findings
during screening, (medical history, physical examination, laboratory evaluations, ECG,
X-ray & lower abdominal ultrasonography recordings).

4. The subjects who have any disease or condition which might compromise the
haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central
nervous system, diabetes, psychosis or any other body system.

5. The subjects who have a history or presence of bronchial asthma.

6. The subject who have used of enzyme-modifying drugs within 30 days prior to receiving
the first dose of study medication.

7. The subjects who have history of drug dependence, recent history of alcoholism or of
moderate alcohol use.

8. The subjects who are smokers, who smoke more than or equal to 10 cigarettes per day or
more than or equal to 20 biddies per day or those who cannot refrain from smoking
during study period.

9. The subjects with a history of difficulty with donating blood or difficulty in
accessibility of veins.

10. The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to
receiving the first dose of study medication.

11. The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).

12. The subjects who have a positive test result for Human Immunodeficiency Virus (HIV)
antibody and / or syphilis Rapid Plasma Reagin, Venereal Disease Research Laboratory
(RPR/VDRL).

13. The subject who received an investigational product, or has participated in a drug
research study within a period of 90 days prior to the first dose of the study
medication administration.