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 ISOXSUPRINE HCl 40 MG (SR) CAPSULES IN HEALTHY INDIAN VOLUNTEERS. Hitesh Verma, Bindia Gupta

BIOEQUIVALENCE STUDY OF ISOXSUPRINE HCl 40 MG (SR) CAPSULES IN HEALTHY INDIAN VOLUNTEERS

Hitesh Verma, Bindia Gupta

International Journal of Pharmacology & Toxicology Science 2013; 3(4): 17-23

Abstract

Present study was aimed to establish bioequivalence between the test and reference dosage form containing Isoxsuprine HCl 40mg as sustained release pellets. A randomized, two way, two period, and two treatment cross over bioequivalence study was performed in twelve healthy human volunteers. A wash out period of one week was given in between two dosing sessions. At specified time intervals blood samples were collected, centrifuged and separated plasma was analyzed by using validated HPLC method. The relative bioavilability of test with respect to reference formulation was found to be 97.48 %. Based on pharmacokinetic parameters viz. Cmax, tmax, AUC0-t, AUC0-inf, t1/2 and Kel, it can be concluded that the test preparation (PREGNIN RETARD) containing Isoxsuprine Hydrochloride 40 mg as sustained release pellets, manufactured at Overseas R & D centre, Overseas Health Care Pvt. Ltd. is bioequivalent to reference formulation.

Key words: Bioequivalence, HPLC, Indian volunteers, Isoxsuprine hydrochloride
Attachments:
Time to create page: 0.11 seconds


Copyright © All rights reserved Science Instinct Publications sciipub.com