Journal of Bioequivalence & Bioavailability

Suhas Sahebrao Khandave

Publications

• Research Article
  Evaluation of Bioequivalence and Cardio-Hepatic Safety of a Single Dose of Fixed Dose Combination of Artemether and Lumefantrine
  Author(s): Suhas Sahebrao Khandave, Santosh Shrikrishna Joshi, Satish Vitthal Sawant and Shahoo Vasant OnkarSuhas Sahebrao Khandave, Santosh Shrikrishna Joshi, Satish Vitthal Sawant and Shahoo Vasant Onkar
  
  Background and objective: The existing fixed-dose combination, Coartem® (artemether 20 mg and lumefantrine 80 mg) requires 4 tablets per dose and a total of 24 tablets for the six-dose regimen for the treatment of uncomplicated P. falciparum malaria compromising the patient compliance. Also, the cardiotoxicity due to lumefantrine because of its structural similarity with halofantrine remains a matter of debate in therapeutics. To enhance the patient compliance, the fixed-dose combination of artemether/lumefantrine (80/480 mg) is formulated by Sequel Pharmachem Pvt. Ltd. India. In the present study, this fixed dose combination (test product) was evaluated for its bioequivalence to the reference product, Coartem® 20/120 mg (artemether 20 mg and lumefantrine 120 mg) of Novartis Pharma Ltd. with assessment of cardio-hepatic safety. Methods: A randomized, open label, two-treatm.. View More»
  DOI: 10.4172/jbb.1000036

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