Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin Calcium Tablets, 80 mg | Experimental | Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Laboratories Limited |
|
| Lipitor 80 mg Tablets | Active Comparator | Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Calcium Tablets, 80 mg | Drug | Atorvastatin Calcium Tablets, 80 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study, if they meet any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 3 80015, | India |
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |