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Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01645410
First received: July 18, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed condition.


Condition Intervention Phase
Healthy
 Drug: Atorvastatin Calcium Tablets, 40 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single Oral Dose, Crossover BE Study of Atorvastatin Ca 40mg Tablets of Dr.Reddy's With Lipitor® 40 mg Tablets of Pfizer in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Calcium Malnutrition
U.S. FDA Resources

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

Primary Outcome Measures:
  • Area under curve (AUC) [ Time Frame: Pre-dose at 0.00 hour and post dose at 0.25, 0.50, 0.75,1.00, 1.25, 1.50, 1.75,2.00,2.25,2.50,2.75,3.00,3.33,3.67,4.00,4.50, 5.00, 6.00,8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin Calcium Tablets, 40 mg
Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
 Drug: Atorvastatin Calcium Tablets, 40 mg
Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
Other Name: Lipitor® 40 mg Tablets
Active Comparator: Lipitor® 40 mg Tablets
Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals
 Drug: Atorvastatin Calcium Tablets, 40 mg
Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
Other Name: Lipitor® 40 mg Tablets

Detailed Description:

Open-label, balanced, randomized, two-treatment, two-sequence,two-period, single-dose, crossover oral bioequivalence study of Atorvastatin calcium 40 mg Tablets of Dr. Reddy's Laboratories Limited, India and Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects aged between 18 and 45 years (both inclusive)
  2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2)with minimum of 50 kg weight.
  3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  4. Subjects having normal 12-lead electrocardiogram (ECG).
  5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
  6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine)/
  7. Subjects having negative alcohol breath test.
  8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

The subjects were excluded from the study, if they meet any of the following criteria:

  1. Hypersensitivity to Atorvastatin or related class of drugs.
  2. History of presence of significant cardiovascular, pulmonary, hepatic,renal, gastrointestinal, endocrine, immunological,dermatological, neurological or psychiatric disease or disorder.
  3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
  4. History or presence of significant alcoholism or drug abuse in the past one year.
  5. History or presence of significant smoking (more than 10 cigarettes of beedi's/day).
  6. History or presence of asthma, urticaria or other significant allergic reactions.
  7. History or presence of significant gastric and/or duodenal ulceration.
  8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  9. History or presence of cancer.
  10. Difficulty with donating blood.
  11. Difficulty in swallowing solids like tablets or capsules.
  12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
  13. Major illness during 3 months before screening.
  14. Participation in a drug research study within past 3 months.
  15. Donation of blood in the past 3 months before screening.
  16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
  17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
  18. History or presence of significant easy bruising or bleeding.
  19. History or presence of significant recent trauma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645410

Locations
India
Veeda Clinical Research Pvt. Ltd.,
Ahmedabad, Gujrat, India, 380 015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Dharmesh Domadia, MD Veeda Clinical Research Pvt. Ltd.,
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01645410     History of Changes
Other Study ID Numbers: 09-VIN-057
Study First Received: July 18, 2012
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Atorvastatin calcium
crossover

Additional relevant MeSH terms:
Calcium, Dietary
Atorvastatin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013