Comparison of Bioavailability and Bioequivalence of Generic and Brand Name Formulations of Escitalopram Oxalate Tablets in Healthy Chinese Population Under Fasting and Fed Conditions

Abstract

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 AUC_0-t, AUC_0-∞, and C_max 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

Acknowledgment

The authors thank the subjects who participated in this trial and the members of the Phase I Clinical Trial Center team of General Hospital of Northern Theater Command for their hard work. This study was financially sponsored by Jewim Pharmaceutical Co., Ltd.

Disclosure

The authors have no conflict of interests in this work.