BA/BE study of Imatinib Mesylate 400 mg Tablets

ABSTRACT: Intervention1: Imatinib Mesylate 400mg Manufactured by Eugia Pharma Specialities Limited, India: This study will consists of two periods and is multiple dose study. Eligible patients will be administered with test (Imatinib Mesylate 400mg ) or reference (Gleevec (Imatinib Mesylate) Tablets 400 mg;)for 7 consecutive days in each period crossed over without washout. Control Intervention1: Gleevec(R) -Imatinib Mesylate 400mg Distributed by Novartis Pharmaceuticals Corporation, USA.: This study will consists of two periods and is multiple dose study. Eligible patients will be administered with test (Imatinib Mesylate 400mg ) or reference (Gleevec (Imatinib Mesylate) Tablets 400 mg;)for 7 consecutive days in each period crossed over without washout. Primary outcome(s): AUC0-� -: Area under the plasma concentration time curve over the steady state dosing interval. Cmax-ss: Maximum concentration over the steady state dosing interval. Timepoint: Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period) Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period. Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label

DISEASE(S): Chronic Myeloid Leukemia, Bcr/abl-positive,Malignant Neoplasm Of Ill-definedsites Within The Digestive System

PROVIDER: 2577939 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR