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

Dr. Reddy's Laboratories Limited1 site in 1 country77 target enrollmentAugust 2009

ConditionsHealthy

InterventionsAtorvastatin Calcium Tablets, 80 mg

DrugsAtorvastatin Calcium Tablets, 80 mg

Overview

Phase: Phase 1
Intervention: Atorvastatin Calcium Tablets, 80 mg
Conditions: Healthy
Sponsor: Dr. Reddy's Laboratories Limited
Enrollment: 77
Locations: 1
Primary Endpoint: Area under curve (AUC)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

September 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Dr. Reddy's Laboratories Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects aged between 18 and 45 years (both inclusive).
•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.
•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).
•Subjects having normal 12-lead electrocardiogram (ECG).
•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
•Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
•Subjects having negative alcohol breath test.
•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:
•Hypersensitivity to Atorvastatin or related class of drugs.
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
•Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
•History or presence of significant alcoholism or drug abuse in the past one year.
•History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
•History or presence of asthma, urticaria or other significant allergic reactions.
•History or presence of significant gastric andlor duodenal ulceration.
•History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
•History or presence of cancer.

Arms & Interventions

Atorvastatin Calcium Tablets, 80 mg

Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Laboratories Limited

Intervention: Atorvastatin Calcium Tablets, 80 mg

Lipitor 80 mg Tablets

Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals

Intervention: Atorvastatin Calcium Tablets, 80 mg

Outcomes

Primary Outcomes

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