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The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and LipitorĀ® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed condition.
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 LipitorĀ® 40 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin Calcium Tablets, 40 mg | Experimental | Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited |
|
| LipitorĀ® 40 mg Tablets | Active Comparator | LipitorĀ® 40 mg Tablets of Pfizer Ireland Pharmaceuticals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Calcium Tablets, 40 mg | Drug | Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
The subjects were excluded from the study, if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Dharmesh Domadia, MD | Veeda Clinical Research Pvt. Ltd., | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veeda Clinical Research Pvt. Ltd., | Ahmedabad | Gujarat | 380 015 | India |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |