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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01645410
• Date of registration: 18/07/2012
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
• Scientific 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
• Date of first enrolment: March 2009
• Target sample size: 71
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01645410
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Dr. Dharmesh Domadia, MD
• Affiliation: Veeda Clinical Research Pvt. Ltd.,

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Atorvastatin Calcium Tablets, 40 mg

Primary Outcome(s)

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]

Secondary ID(s)

09-VIN-057

Source(s) of Monetary Support

Please refer to primary and secondary sponsors