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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01155947
First received: July 1, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Anastrozole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability based on Cmax and AUC parameters [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   37 Years to 67 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155947

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mayur Soni, MBBS BA Research India Ltd.,
  More Information

No publications provided

Responsible Party: Dr. Ramesh Mullangi -Director, Dr.Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01155947     History of Changes
Other Study ID Numbers: BA0859093
Study First Received: July 1, 2010
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability
Anastrozole
Crossover

Additional relevant MeSH terms:
Anastrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014