A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions
This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80 mg tablet) in healthy adult subjects when administered under fed conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions.|
- Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Atorvastatin. [ Time Frame: 0, 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Atorvastatin Calcium Tablets of OHM Laboratories Inc.
80 Mg tablets
Active Comparator: 2
LIPITOR® Tablets 80mg of Pfizer Ireland Pharmaceuticals
80 Mg tablets
This was an open-label, balanced, randomized, two-period, two-treatment, two-sequence, single-dose crossover bioequivalence study under fed conditions. The total duration of the study, screening through study exit, was approximately 8 weeks with at least a 14-day washout period between doses. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours. A total of 25 blood samples were collected per study period for a total of 50 samples or 150 mL total volume.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499771
|United States, North Dakota|
|Cetero Research 4801 Amber Valley Parkway|
|Fargo, North Dakota, United States, 58104|