Comparison of Bioavailability and Bioequivalence of Generic and Brand Name Formulations of Escitalopram Oxalate Tablets in Healthy Chinese Population Under Fasting and Fed Conditions
| Autor: | Hua Huo, Yunbiao Tang, Wenli Hu, Yin Sui, Qiuying Li |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty escitalopram Drug Compounding Cmax Pharmaceutical Science Biological Availability Bioequivalence Citalopram Gastroenterology 03 medical and health sciences Food-Drug Interactions 0302 clinical medicine Pharmacokinetics Asian People Internal medicine Drug Discovery medicine Escitalopram Drugs Generic Humans LC-MS/MS Original Research Pharmacology clinical trials bioequivalence Drug Design Development and Therapy Cross-Over Studies Molecular Structure business.industry escitalopram oxalate tablets Fasting Escitalopram Oxalate Crossover study Healthy Volunteers Bioavailability 030104 developmental biology Tolerability 030220 oncology & carcinogenesis Female business pharmacokinetics medicine.drug Tablets |
| Zdroj: | Drug Design, Development and Therapy |
| ISSN: | 1177-8881 |
| Popis: | Qiuying Li, Hua Huo, Wenli Hu, Yin Sui, Yunbiao Tang Department of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang 110840, People’s Republic of ChinaCorrespondence: Yunbiao Tang; Hua HuoDepartment of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang, People’s Republic of ChinaTel/Fax +86-24-28897206Email tangyb99@163.com; SZYQBGS@163.comPurpose: 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 |
| Databáze: | OpenAIRE |
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