Clinical trial NCT01645423: Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Atorvastatin calcium
crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Veeda Clinical Research Pvt. Ltd.,
state: Gujrat
Study officials:
affiliation: Veeda Clinical Research Pvt. Ltd.,
name: Dr. Dharmesh Domadia, MD
role: PRINCIPAL_INVESTIGATOR
References: