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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Atorvastatin Calcium Tablets, 40 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujrat
    • Ahmedabad, Gujrat, India, 380 015
      • Veeda Clinical Research Pvt. Ltd.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Lipitor® 40 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under curve (AUC)	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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (ESTIMATE): July 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Bioequivalence; crossover; Atorvastatin calcium
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Calcium-Regulating Hormones and Agents; Atorvastatin; Calcium
• Other Study ID Numbers: 09-VIN-057