<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2d1 20170631//EN" "JATS-journalpublishing1.dtd">
<article xlink="http://www.w3.org/1999/xlink" dtd-version="1.0" article-type="healthcare" lang="en"><front><journal-meta><journal-id journal-id-type="publisher">IJCRR</journal-id><journal-id journal-id-type="nlm-ta">I Journ Cur Res Re</journal-id><journal-title-group><journal-title>International Journal of Current Research and Review</journal-title><abbrev-journal-title abbrev-type="pubmed">I Journ Cur Res Re</abbrev-journal-title></journal-title-group><issn pub-type="ppub">2231-2196</issn><issn pub-type="opub">0975-5241</issn><publisher><publisher-name>Radiance Research Academy</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">290</article-id><article-id pub-id-type="doi"/><article-id pub-id-type="doi-url"/><article-categories><subj-group subj-group-type="heading"><subject>Healthcare</subject></subj-group></article-categories><title-group><article-title>BIOAVAILABILITY AND BIOEQUIVALENCE EVALUATION OF SOME GENERIC PRODUCTS OF ARTEMETHER-LUMEFANTRINE DOUBLE STRENGTH TABLETS MARKETED IN NIGERIA&#13;
</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>O.</surname><given-names>Awofisayo Sunday</given-names></name></contrib><contrib contrib-type="author"><name><surname>O.</surname><given-names>Okhamafe Augustine</given-names></name></contrib><contrib contrib-type="author"><name><surname>I.</surname><given-names>Arhewoh Matthew</given-names></name></contrib></contrib-group><pub-date pub-type="ppub"><day>20</day><month>04</month><year>2016</year></pub-date><volume/><issue/><fpage>8</fpage><lpage>14</lpage><permissions><copyright-statement>This article is copyright of Popeye Publishing, 2009</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access" href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence, and indicate if changes were made.</license-p></license></permissions><abstract><p>The study was aimed at evaluating the bioavailability and bioequivalence of generic products of artemether-lumefantrine (AL) antimalarial double strength oral tablet formulation. A non-randomized open label single dose study in eighteen healthy African male subjects was designed. The volunteers were administered one tablet of a product with a fatty meal and 0.5 L of water, after overnight fast. Venous blood sampling was taken at 0, 1, 2, 4, 6 and 8 h post-dose and plasma samples analyzed for artemether and lumefantrine exposure simultaneously using a validated high performance liquid chromatographic system with Chromosil C18 column, flow rate and UV detection at 1.0 mL/min and 216 nm, respectively. Acetonitrile: potassium dihydrogen phosphate (70: 30%, v/v) and nevirapine were employed as mobile phase and internal standard, respectively. The primary endpoints were area under the plasma concentration time curve (AUC) from zero to 8 h and maximum plasma concentration (Cmax). The 90% confidence interval for the ratio of the geometric means of AUC0-8 was compared with the established bioequivalence limit. All enrolled subjects with mean age 28.5 __ampersandsignplusmn; 4.5 years completed the study. The Cmax for artemether and lumefantrine for the products ranged from 0.225 - 0.558 __ampersandsignmicro;g/mL and 0.319 __ampersandsignndash; 0.517 __ampersandsignmicro;g/mL, respectively. Drug products AL1 and AL2 met the bioequivalence criteria. The other products failed the pharmacopoeia test specification for chemical content with respect to either or both API and their pharmacokinetic profiles varied with statistical significant differences (P__ampersandsigngt;0.05). Only two of the generic products studied were bioequivalent and could be switched.&#13;
</p></abstract><kwd-group><kwd>Bioavailability</kwd><kwd> Bioequivalence</kwd><kwd> Pharmacokinetics</kwd><kwd> Artemether</kwd><kwd> Lumefantrine</kwd></kwd-group></article-meta></front></article>
