Journal of Bioequivalence & Bioavailability

Bioequivalence study of 20 mg Escitalopram formulations after single-dose administration in healthy Indonesian subjects

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Yahdiana Harahap1, Budi Prasaja2, Windy Lusthom2, Theresia Sinandang2, Lia Y Yusvita2, Vita Felicia2 and Lianna Y Panjaitan2

Posters-Accepted Abstracts: J Bioequiv Availab

Abstract:

Purpose: Escitalopram is an oral drug that is used to treating depression and generalized anxiety disorder. In this research we
conducted the bioequivalence study of 20 mg Escitalopram formulations in healthy Indonesian subjects.
Methods: This study was conducted in randomized two-way crossover design with three-week -wash-out period under fasting
condition on 23 subjects. Subjects were fasted 10 hours before each drug administration. Each subject received one tablet of 20 mg
Escitalopram with 240 ml of water. Serial blood samples were collected at the following time points: before dosing 1, 1.5, 2, 2.5, 3, 3.5,
4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours after drug administration. The concentration of escitalopram in plasma was determined
using LC-MS/MS method with Turbolon Spray (Electrospray) ionization mode. Pharmacokinetic parameters AUC0-t, and Cmax were
tested for bioequivalence after log-transformation of data.
Results: The result showed that the AUC0-72h still covered less than 80% of AUC0-∞ in more than 20% of the observations;
therefore the AUC0-∞ and t1/2 were not evaluated. The point estimates and 90% confidence intervals (CI) for AUC0-t and Cmax for
escilatalopram were 92.64% (89.25-96.15%) and 95.31% (89.33-101.69%) respectively.
Conclusion: These results indicated that the two formulations of escitalopram were bioequivalent.