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

• ClinicalTrials.gov Identifier: NCT01155947
• Recruitment Status: Completed
• First Posted: July 2, 2010
• Last Update Posted: July 2, 2010
• Sponsor: Dr. Reddy's Laboratories Limited
• Information provided by: Dr. Reddy's Laboratories Limited

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Anastrozole	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: May 2008
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arimidex; Arimidex® Tablets 1 mg	Drug: Anastrozole; Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited; Other Name: 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 Name: Arimidex® Tablets 1 mg

Outcome Measures

Primary Outcome Measures :

1. Bioavailability based on Cmax and AUC parameters [ Time Frame: 3 Months ]

Eligibility Criteria

• Ages Eligible for Study: 37 Years to 67 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

Dr. Reddy's Laboratories Limited

Investigators

• Principal Investigator: Mayur Soni, MBBS; BA Research India Ltd.,

More Information

• Responsible Party: Dr. Ramesh Mullangi -Director, Dr.Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT01155947
• Other Study ID Numbers: BA0859093
• First Posted: July 2, 2010
• Last Update Posted: July 2, 2010
• Last Verified: July 2010

Keywords provided by Dr. Reddy's Laboratories Limited:

Bioavailability; Anastrozole; Crossover

Additional relevant MeSH terms:

Anastrozole; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs