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

An Open Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two Period, Crossover, Single Dose Comparative Oral Bioavailability Study Of Anastrozole Tablets 1 mg (Test) Of Dr. Reddy's Laboratories Ltd., India And ARIMIDEX® Tablets 1 mg (Reference) Of Astrazeneca Pharmaceuticals LP, USA In Post Menopausal Healthy Women Subjects Under Fasting Conditions.

The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Anastrozole

Detailed Description

Open label, balanced, randomized, two treatment, two-sequence, two periods, crossover, single dose, comparative oral bioavailability study in healthy, post menopausal women subjects under fasting conditions.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arimidex; Arimidex® Tablets 1 mg	Drug: Anastrozole; Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited; Other Names: Arimidex® Tablets 1 mg
Experimental: Anastrozole; Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited	Drug: Anastrozole; Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited; Other Names: Arimidex® Tablets 1 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioavailability based on Cmax and AUC parameters	3 Months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Mayur Soni, MBBS, BA Research India Ltd.,

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2010
• Last Update Submitted That Met QC Criteria: July 1, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Crossover; Bioavailability; Anastrozole
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: BA0859093