Madhava Rao Betha, S. Tippabhotla, Sandeep Yergude, Sohel Md. Khan, Mukesh Nakkawar, C. Gadiko, S. Thota, Raju Cheerla, R. Battula, V. Vobalaboina
{"title":"Steady-state pharmacokinetics and bioequivalence study of quetiapine fumarate film-coated tablets 300 mg in adult schizophrenic patients","authors":"Madhava Rao Betha, S. Tippabhotla, Sandeep Yergude, Sohel Md. Khan, Mukesh Nakkawar, C. Gadiko, S. Thota, Raju Cheerla, R. Battula, V. Vobalaboina","doi":"10.3109/10601333.2012.740485","DOIUrl":null,"url":null,"abstract":"Quetiapine is a dibenzothiazepine derivative approved for the treatment of schizophrenia and related psychoses. The objective of the present study was to design and evaluate the bioequivalence between quetiapine fumarate film-coated tablets of Dr. Reddy’s Laboratories Ltd., Hyderabad, India (test) and Seroquel® tablets (containing quetiapine) of AstraZeneca Pharmaceuticals LP Wilmington, DE, USA (reference). It was a two-way crossover steady-state multiple dose study in 54 adult schizophrenic patients under fasting conditions. Quetiapine was analyzed in plasma samples by using a validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters were estimated by noncompartmental method and mean (±SD) of Cmax,ss (ng/mL) for test and reference products were 1436.5 (±810.2) and 1413.1 (±905.5), respectively. The mean (±SD) of AUCτ,ss (ng·h/mL) for test and reference products were 6949.8 (±3879.8) and 6532.2 (±4279.4), respectively. The ratio of least square means and its 90% confidence interval for Cmax,ss and AUCτ,ss were found to be within bioequivalence limits 80.00–125.00%. In conclusion, test product was bioequivalent to the reference product in terms of both rate and extent of absorption under steady-state conditions.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"57 1","pages":"65 - 71"},"PeriodicalIF":0.0000,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2012.740485","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Quetiapine is a dibenzothiazepine derivative approved for the treatment of schizophrenia and related psychoses. The objective of the present study was to design and evaluate the bioequivalence between quetiapine fumarate film-coated tablets of Dr. Reddy’s Laboratories Ltd., Hyderabad, India (test) and Seroquel® tablets (containing quetiapine) of AstraZeneca Pharmaceuticals LP Wilmington, DE, USA (reference). It was a two-way crossover steady-state multiple dose study in 54 adult schizophrenic patients under fasting conditions. Quetiapine was analyzed in plasma samples by using a validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters were estimated by noncompartmental method and mean (±SD) of Cmax,ss (ng/mL) for test and reference products were 1436.5 (±810.2) and 1413.1 (±905.5), respectively. The mean (±SD) of AUCτ,ss (ng·h/mL) for test and reference products were 6949.8 (±3879.8) and 6532.2 (±4279.4), respectively. The ratio of least square means and its 90% confidence interval for Cmax,ss and AUCτ,ss were found to be within bioequivalence limits 80.00–125.00%. In conclusion, test product was bioequivalent to the reference product in terms of both rate and extent of absorption under steady-state conditions.