HIGH QUALITY SCIENTIFIC CONTENT,  ONLINE OPEN ACCESS,  GLOBAL SCIENTIFIC AUDIENCE,  COST EFFECTIVE, ANY ONE CAN DOWNLOAD REPRINTS 
Spreading knowledge

Google Scholar

Google Scholar

Archives

Back 

BIOEQUIVALENCE STUDY OF FIXED DOSE COMBINATION OF RABEPRAZOLE (EC) AND DOMPERIDONE (SR) IN HEALTHY INDIAN VOLUNTEERS. Hitesh Verma, Bindia Gupta

BIOEQUIVALENCE STUDY OF FIXED DOSE COMBINATION OF RABEPRAZOLE (EC) AND DOMPERIDONE (SR) IN HEALTHY INDIAN VOLUNTEERS

Hitesh Verma, Bindia Gupta

International Journal of Pharmacology & Toxicology Science 2013; 3(4): 10-16

Abstract

Present study was aimed to establish bioequivalence between the test (RABEDIF, Overseas Health Care Pvt. Ltd.) and reference formulation containing Rabeprazole 20 mg (enteric coated pellets) and Domperidone 30mg (sustained release pellets). A randomized, two way, two period, and two treatment cross over bioequivalence study was performed in 12 healthy human male volunteers. A wash out period of one week was given in between two successive treatments. At specified time intervals blood samples were collected, centrifuged and separated plasma was analyzed by using validated LC-MS/MS method. The relative bioavailability of test formulation with respect to reference formulation was found to be 98.42 % for Rabeprazole and 95.85 % for Domperidone, respectively. On the basis of pharmacokinetic parameters viz. Cmax, tmax, AUC0-t, AUC0-inf, t1/2 and Kel, it can be concluded that the test preparation of FDC capsule, containing Rabeprazole 20 mg (enteric coated pellets) and Domperidone 30 mg (sustained release pellets), manufactured at Overseas R & D Centre, Overseas Health Care Pvt. Ltd. is bioequivalent to reference formulation.

Key words: Bioequivalence, Domperidone, LC-MS/MS, Rabeprazole
Attachments:
Time to create page: 0.16 seconds


Copyright © All rights reserved Science Instinct Publications sciipub.com