{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T13:28:01Z","timestamp":1777728481779,"version":"3.51.4"},"reference-count":27,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2014,2,19]],"date-time":"2014-02-19T00:00:00Z","timestamp":1392768000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"},{"start":{"date-parts":[[2014,2,19]],"date-time":"2014-02-19T00:00:00Z","timestamp":1392768000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Int Med Res"],"published-print":{"date-parts":[[2014,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The primary objective of this study was to compare the bioavailability of paracetamol, phenylephrine hydrochoride and guaifenesin in a new oral syrup with an established oral reference product. The secondary objective was to compare the safety of the new syrup and the reference product.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a single-centre, open-label, randomized, reference-replicated, crossover study. Healthy adult volunteers received one dose of syrup and two separate doses of a reference oral liquid formulation in a randomized sequence over three study periods, with a washout interval of \u22657 days between study periods. Blood samples were taken regularly postdose and analysed for paracetamol, phenylephrine hydrochoride and guaifenesin concentrations; adverse events were recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>This study enrolled 45 subjects. For paracetamol and guaifenesin, the syrup and reference product were considered to be bioequivalent. Bioequivalence was not shown for phenylephrine hydrochoride. All adverse events were mild or moderate, most of which were considered formulation related.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The syrup did not reach bioequivalence with the reference product, as bioequivalence could not be shown for phenylephrine hydrochoride. This may be due to differences in the excipients between the two products. Both the syrup and the reference product had a good safety profile and were well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0300060513503762","type":"journal-article","created":{"date-parts":[[2014,2,19]],"date-time":"2014-02-19T21:43:06Z","timestamp":1392846186000},"page":"347-359","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["Bioavailability of paracetamol, phenylephrine hydrochloride and guaifenesin in a fixed-combination syrup versus an oral reference product"],"prefix":"10.1177","volume":"42","author":[{"given":"Annick","family":"Janin","sequence":"first","affiliation":[{"name":"Novartis Consumer Health S.A., Nyon, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joelle","family":"Monnet","sequence":"additional","affiliation":[{"name":"Novartis Consumer Health S.A., Nyon, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2014,2,19]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"GlaxoSmithKline Consumer Healthcare. Beechams All-In-One SmPC. Datapharm Leatherhead England. Available at: www.medicines.org.uk\/emc\/medicine\/23679\/SPC\/Beechams+All+in+One+Liquid+(P) (2011 accessed October 2013)."},{"key":"e_1_3_4_3_2","unstructured":"Novartis. The power of Theraflu. Novartis Consumer Health Inc. Parsippany New Jersey USA. Available at: www.theraflu.com\/theraflu_products.shtml (2013 accessed October 2013)."},{"key":"e_1_3_4_4_2","unstructured":"Reckitt Benckiser Healthcare (UK) Ltd. Lemsip SmPC. Datapharm Leatherhead England. Available at: www.medicines.org.uk\/emc\/medicine\/26946\/SPC (2013 accessed October 2013)."},{"key":"e_1_3_4_5_2","volume-title":"Martindale: The complete drug reference","author":"Sweetman S","year":"2012","unstructured":"Sweetman S. Martindale: The complete drug reference, London: Pharmaceutical Press, 2012. (electronic version)."},{"key":"e_1_3_4_6_2","first-page":"67","volume-title":"Paracetamol (acetaminophen). A critical bibliographic review","author":"Prescott LF","year":"1996","unstructured":"Prescott LF The metabolism of paracetamol. In: Prescott LF (ed). Paracetamol (acetaminophen). A critical bibliographic review, London: Taylor and Francis, 1996, pp. 67\u2013102."},{"key":"e_1_3_4_7_2","volume-title":"Goodman and Gilman\u2019s the pharmacological basis of therapeutics","author":"Hardman JG","year":"2001","unstructured":"Hardman JG, Limbird LE. Goodman and Gilman\u2019s the pharmacological basis of therapeutics, 10th ed. New York: McGraw-Hill, 2001.","edition":"10"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2007.02935.x"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1H679"},{"issue":"2","key":"e_1_3_4_10_2","first-page":"116S","article-title":"Pharmacokinetics of oral decongestants","volume":"13","author":"Kanfer I","year":"1993","unstructured":"Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy 1993; 13(Pt 2): 116S\u2013128S.","journal-title":"Pharmacotherapy"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.2042-7158.1983.tb04293.x"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF00637623"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/thx.28.6.742"},{"key":"e_1_3_4_14_2","first-page":"284","article-title":"Effectiveness of guaifenesin as an expectorant: a cooperative double-blind study","volume":"22","author":"Robinson RE","year":"1977","unstructured":"Robinson RE, Cummings WB, Deffenbach ER. Effectiveness of guaifenesin as an expectorant: a cooperative double-blind study. Curr Ther Res 1977; 22: 284\u2013296.","journal-title":"Curr Ther Res"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600590930"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600611226"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600520315"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF00607955"},{"key":"e_1_3_4_19_2","unstructured":"European Medicines Agency. Guideline on the investigation of bioequivalence doc. ref. CPMP\/EWP\/QWP\/1401\/98 Rev 1\/Corr **. London: European Medicines Agency. Available at: www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2011\/11\/WC500117887.pdf (accessed December 2013)."},{"key":"e_1_3_4_20_2","unstructured":"ICH. Validation of analytical procedures: text and methodology Q2 (R1). 2005. Available at: http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q2_R1\/Step4\/Q2_R1__Guideline.pdf. (accessed December 2013)."},{"key":"e_1_3_4_21_2","first-page":"768","article-title":"Digestion and absorption of sorbitol, maltitol and isomalt from the small bowel. A study in ileostomy subjects","volume":"48","author":"Langkilde AM","year":"1994","unstructured":"Langkilde AM, Andersson H, Schweizer TF, et al. Digestion and absorption of sorbitol, maltitol and isomalt from the small bowel. A study in ileostomy subjects. Eur J Clin Nutr 1994; 48: 768\u2013775.","journal-title":"Eur J Clin Nutr"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1529\/biophysj.105.067330"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2982.2006.00757.x"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-006-9120-4"},{"key":"e_1_3_4_25_2","unstructured":"CHMP Pharmacokinetics Working Party (PKWP). Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party. London: European Medicines Agency. Available at: www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500002963.pdf (2001 accessed September 2012)."},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-012-9382-1"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.5414\/CPP45293"},{"key":"e_1_3_4_28_2","unstructured":"European Medicines Agency. Guideline on bioanalytical method validation doc. ref. EMEA\/CHMP\/EWP\/192217\/2009. London: European Medicines Agency. Available at: www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2011\/08\/WC500109686.pdf (2011 accessed October 2013)."}],"updated-by":[{"DOI":"10.1177\/0300060514533283","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2014,6,5]],"date-time":"2014-06-05T00:00:00Z","timestamp":1401926400000}}],"container-title":["Journal of International Medical Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0300060513503762","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0300060513503762","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0300060513503762","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T10:52:14Z","timestamp":1777459934000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0300060513503762"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,2,19]]},"references-count":27,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2014,4]]}},"alternative-id":["10.1177\/0300060513503762"],"URL":"https:\/\/doi.org\/10.1177\/0300060513503762","relation":{},"ISSN":["0300-0605","1473-2300"],"issn-type":[{"value":"0300-0605","type":"print"},{"value":"1473-2300","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,2,19]]}}}