2009
DOI: 10.1590/s1984-82502009000400011
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Abstract: Secnidazole is an antimicrobial agent used primarily in the treatment of amoebiasis. For this bioequivalence study of secnidazole, twenty-eight healthy female volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of secnidazole test preparation and then the reference preparation, or vice versa, with a wash out interval of two weeks. The plasma concentrations of secnidazole were determined by HPLC, and the samples were extracted with tert-butyl-methyl-ether: diclo… Show more

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Cited by 9 publications
(8 citation statements)
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“…This similarity of findings across the studies may be related to consistency of the formulation as well as the close similarity of population and methods used in both. However, the PK values observed in studies 102 and 103 are similar to previously reported PK values for different formulations of secnidazole administered orally at 2 g in healthy female volunteers …”
Section: Discussionsupporting
confidence: 88%
See 1 more Smart Citation
“…This similarity of findings across the studies may be related to consistency of the formulation as well as the close similarity of population and methods used in both. However, the PK values observed in studies 102 and 103 are similar to previously reported PK values for different formulations of secnidazole administered orally at 2 g in healthy female volunteers …”
Section: Discussionsupporting
confidence: 88%
“…However, the PK values observed in studies 102 and 103 are similar to previously reported PK values for different formulations of secnidazole administered orally at 2 g in healthy female volunteers. 32 Overall, the data from these 2 studies indicate a consistency of bioavailability, t ½ , and other PK parameters of SYM-1219 across food and fasting states and administration in different foods. Three single SYM-1219 doses administered in a crossover design were also well tolerated in both studies under the different treatment conditions assessed.…”
Section: Discussionmentioning
confidence: 81%
“…No separate analysis was performed for randomized participants only. Several attempts to contact study authors were unsuccessfulMontovani 2009Not an RCT. Bioequivalence study comparing 2 oral formulations of secnidazoleMorales 1975Ineligible study population: RCT that compared intravenous metronidazole vs intramuscular emetine for treating patients with amoebic liver abscessMurray 1980Wrong intervention: did not study effect of any antiamoebic drug for treating patients with amoebic colitisMuzzafar 2006Ineligible study population: amoebic liver abscessNahrevanian 2008Ineligible study population and not an RCT: study to determine prevalence of Cryptosporidium in immunocompromised patientsNaik 1968Not an RCTNanavati 1965Not an RCTO'Holohan 1972Not an RCTOhnishi 2014Not an RCTOkeniyi 2007Ineligible study population: no mention of amoebic colitisOlaeta 1996Not an RCT: quasi ‐randomized trial with alternate allocation of participants with intestinal amoebiasis to receive either quinfamide or etofamideOmrani 1995Not an RCTOrozco 1975Ineligible study population: amoebic liver abscessPadilla 1995Ineligible study population: asymptomatic amoebic infectionPadilla 1998Unclear whether an RCTPadilla 2002Wrong intervention and ineligible study population: RCT in which children whose stools became negative for E histolytica cysts and who were asymptomatic after 1 or 2 doses of quinfamide were randomized to 3 groups to determine whether administering quinfamide every 3 to 6 months resulted in reduced frequency of amoebic infection to below 27%Pang 2014Not an RCTPimparkar 1966Not an RCTPopulaire 1980Not an RCT; pharmacokinetic study of secnidazole given to healthy human volunteersPowell 1965aNot an RCTPowell 1965bIneligible study population: clinical trial of dehydroemetine, emetine, and c...…”
Section: Characteristics Of Excluded Studies [Ordered By Study Id]mentioning
confidence: 99%
“…These include high performance liquid chromatography (HPLC) (KHAN et al, 2015;RAVI et al, 1997;EL WALILY et al, 2000), UV spectrophotometric (SONPETKAR et al, 2012), colorimetric method (EL WALILY et al, 2000), and supercritical fluid chromatography (PATEL et al, 1998). Other methods have been performed for the determination of secnidazole in biological fluids such as polarography (LICHTIG;ANDRADE;VAZ, 1996) and HPLC (RAVI et al, 1997;MONTOVANI et al, 2009). Studies about stability were conducted using HPLC (KHAN et al, 2015;BAKSHI;SINGH, 2004;MIRABAL et al, 2003) and spectrophotometric method (RIVERA et al, 2000).…”
Section: Secnidazolementioning
confidence: 99%