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Trial record 12 of 1432 for:    Area Under Curve AND tablet

Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01645423
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Atorvastatin Calcium Tablets, 80 mg Phase 1

Detailed Description:
An open label, balanced, randomized, two-treatment, two-period, two-way crossover oral bioequivalence' study of Atorvastatin Calcium 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy adult, human subjects under fed conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-way Crossover Oral BE Study of Atorvastatin Ca 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer in Healthy Adult, Human Subjects Under Fed Conditions
Study Start Date : August 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Malnutrition

Arm Intervention/treatment
Experimental: Atorvastatin Calcium Tablets, 80 mg
Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Laboratories Limited
Drug: Atorvastatin Calcium Tablets, 80 mg
Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Other Name: Lipitor 80 mg Tablets

Active Comparator: Lipitor 80 mg Tablets
Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals
Drug: Atorvastatin Calcium Tablets, 80 mg
Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Other Name: Lipitor 80 mg Tablets




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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 (1 8.5 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 (Annexure IIIa) within the clinically acceptable reference range (Annexure IIIb).
  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 0 1.
  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:

Subjects will be excluded from the study, if they meet any of the following criteria:

  1. Hypersensitivity to Atorvastatin or related class of drugs.
  2. History or 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 or beedi's/day).
  6. History or presence of asthma, urticaria or other significant allergic reactions.
  7. History or presence of significant gastric andlor 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 0 1.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645423


Locations
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India
Veeda Clinical Research Pvt. Ltd.,
Ahmedabad, Gujrat, India, 3 80015,
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr. Dharmesh Domadia, MD Veeda Clinical Research Pvt. Ltd.,

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01645423     History of Changes
Other Study ID Numbers: 09-VIN-105
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012
Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Atorvastatin calcium
crossover
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Calcium, Dietary
Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors