A randomized, crossover study to determine bioequivalence of S-Etodolac ER tablets versus Etodolac ER tablets in healthy Indian subjects.
Objective To estimate the bioavailability and evaluate bioequivalence of S-Etodolac 300 mg tablet and to compare it with that of Etodolac 600 mg tablet Materials and Methods Using a two-treatment, two-period, twosequence, randomized crossover design, test and reference formulations were administered...
| Publicado en: | Journal of Applied Research Vol. 9; no. 3; pp. 57 - 63 |
|---|---|
| Autores principales: | , , , , |
| Formato: | research Journal Article |
| Publicado: |
Therapeutic Solutions LLC
2009
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105273478&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105273478 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 1537064X I4L jtl: Journal of Applied Research issn: 1537064X maglogo: N pubinfo: dt: 2009 vid: 9 iid: 3 pid: 13467 pub: Therapeutic Solutions LLC place: Newtown, Pennsylvania artinfo: ui: 105273478 105273478 2010513957 105273478 ppf: 57 ppct: 6 formats: fmt: @attributes: type: P tig: atl: A randomized, crossover study to determine bioequivalence of S-Etodolac ER tablets versus Etodolac ER tablets in healthy Indian subjects. aug: au: Menon S Kadam N Gursale A Gokarn V Palekar A sug: subj: Antiinflammatory Agents, Non-Steroidal Administration and Dosage Dosage Forms Evaluation Inflammation Therapy Administration, Oral Asians Data Analysis Methods Research ab: Objective To estimate the bioavailability and evaluate bioequivalence of S-Etodolac 300 mg tablet and to compare it with that of Etodolac 600 mg tablet Materials and Methods Using a two-treatment, two-period, twosequence, randomized crossover design, test and reference formulations were administered as individual single doses to 24 healthy adult Asian male subjects of Indian origin under non-fed conditions, with one week washout period between dosing. Pharmacokinetic parameters, Cmax, AUC0-t, AUC0--infinity and Cmax/AUC0--infinity were calculated from the plasma concentration-time data of each individual and during each period by applying non-compartmental analysis. Analysis of variance was carried out using logarithmically transformed and non-transformed values of the stated pharmacokinetic parameters. Data for test and reference formulations were analyzed statistically to test for bioequivalence of the two formulations. Results and Discussion All subjects completed the study. After oral administration the mean values of Cmax (ug/ml), AUC0-t (ug/ml*h), and AUC0-infinity (ug/ml*h) for reference and test formulations were 3.94 and 4.07, 23.02 and 23.20, 27.49 and 28.42, respectively. ANOVA and CI test showed no significant (p > 0.05) variation in these pharmacokinetic parameters of test and reference formulations. The T/R ratio of geometric mean of Cmax, AUC0-t and AUC0--infinity for S-etodolac in both formulations was 106.94%, 103.93% and 105.64% respectively. These values are within the acceptance limit of 80 - 120%. No adverse events or clinically significant changes were observed in any of the subjects during the two runs of the study. Conclusion The test formulation containing S-Etodolac 300 mg was bioequivalent to S-Etodolac from reference formulation (Etodolac 600 mg). pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|