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Comparison of Bioavailability and Bioequivalence of Generic and Brand Name Formulations of Escitalopram Oxalate Tablets in Healthy Chinese Population Under Fasting and Fed Conditions
Drug Design, Development and Therapy ( IF 4.8 ) Pub Date : 2020-11-24 , DOI: 10.2147/dddt.s271970 Qiuying Li 1 , Hua Huo 1 , Wenli Hu 1 , Yin Sui 1 , Yunbiao Tang 1
Drug Design, Development and Therapy ( IF 4.8 ) Pub Date : 2020-11-24 , DOI: 10.2147/dddt.s271970 Qiuying Li 1 , Hua Huo 1 , Wenli Hu 1 , Yin Sui 1 , Yunbiao Tang 1
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Purpose: This study compared the bioequivalence of two formulations of escitalopram oxalate 20 mg tablets in terms of bioavailability and tolerability in healthy Chinese male and female subjects.
Patients and Methods: A randomized, single-blind, two-period, two-sequence crossover study was performed under fasting and fed conditions, with a 21-day washout period. In total, 24 healthy subjects (18 males and 6 females) were enrolled in the fasting test and the fed test, respectively. Blood samples were collected over 168 h post-dose in each period. The concentrations of escitalopram in plasma were determined by high-performance liquid chromatography coupled with a tandem mass spectrometry. Pharmacokinetic parameters used for bioequivalence assessment were determined from the drug concentration data using noncompartmental analysis.
Results: All subjects showed good medication compliance. The 90% confidence intervals (CIs) for the geometric mean ratios of AUC0-t, AUC0-∞, and Cmax were within the bioequivalence acceptance criteria (80.00% to 125.00%). Adverse events were recorded and no deaths or serious adverse events (SAEs) occurred.
Conclusion: Escitalopram oxalate 20 mg tablets produced in China were bioequivalent to the reference formulation (Lexapro®) in healthy Chinese male and female subjects under fasting and fed conditions.
Keywords: escitalopram, escitalopram oxalate tablets, clinical trials, LC-MS/MS, pharmacokinetics, bioequivalence
更新日期：2020-11-25
Patients and Methods: A randomized, single-blind, two-period, two-sequence crossover study was performed under fasting and fed conditions, with a 21-day washout period. In total, 24 healthy subjects (18 males and 6 females) were enrolled in the fasting test and the fed test, respectively. Blood samples were collected over 168 h post-dose in each period. The concentrations of escitalopram in plasma were determined by high-performance liquid chromatography coupled with a tandem mass spectrometry. Pharmacokinetic parameters used for bioequivalence assessment were determined from the drug concentration data using noncompartmental analysis.
Results: All subjects showed good medication compliance. The 90% confidence intervals (CIs) for the geometric mean ratios of AUC0-t, AUC0-∞, and Cmax were within the bioequivalence acceptance criteria (80.00% to 125.00%). Adverse events were recorded and no deaths or serious adverse events (SAEs) occurred.
Conclusion: Escitalopram oxalate 20 mg tablets produced in China were bioequivalent to the reference formulation (Lexapro®) in healthy Chinese male and female subjects under fasting and fed conditions.
Keywords: escitalopram, escitalopram oxalate tablets, clinical trials, LC-MS/MS, pharmacokinetics, bioequivalence
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