Comparative bioavailability of two escitalopram formulations in healthy human volunteers
| Autor: | Lu Shi Chen, Tainah Babadópulos, Gustavo D. Mendes, G. De Nucci, Fernando R. Báu |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male Spectrometry Mass Electrospray Ionization Adolescent Biological Availability Bioequivalence Citalopram Young Adult Pharmacokinetics Tandem Mass Spectrometry medicine Escitalopram Humans Pharmacology (medical) Pharmacology Chromatography Cross-Over Studies Chemistry Selected reaction monitoring Middle Aged Crossover study Confidence interval Bioavailability Therapeutic Equivalency Area Under Curve Female Geometric mean Selective Serotonin Reuptake Inhibitors medicine.drug Chromatography Liquid Tablets |
| Zdroj: | International journal of clinical pharmacology and therapeutics. 48(8) |
| ISSN: | 0946-1965 |
| Popis: | Objective: To assess the bio-equivalence of two escitalopram formulations (Test formulation: escitalopram (10 mg tablet) manufactured by Apsen Farmaceutica S.A.) Reference formulation: escitalopram (Lexapro ® ; 10 mg tablet) from Lundbeck Brasil Ltda) in healthy volunteers of both sexes. Methods: The study was conducted using an open, randomized, two-period crossover design with at least a 21-day washout interval. Plasma samples were obtained over a 168 h period. Plasma escitalopram concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). The following pharmacokinetic parameters were obtained from the escitalopram plasma concentration vs. time curves: AUC last , AUC inf and C max . Results: The limit of quantification for escitalopram was 0.2 ng.ml -1 . The geometric mean with corresponding 90% confidence interval (CI) for Test/Reference percent ratios were 97.35% (90% CI = 90.28 - 104.96%) for C max , 99.60% (90% CI = 92.93 - 106.74%) for AUC last and 99.92% (90% CI = 93.34 - 106.97%) for AUC inf . Conclusion: Since the 90% CI for AUC last , AUC inf and C max ratios were within the 80 - 125% interval proposed by the US FDA, it was concluded that escitalopram formulation manufactured by Apsen Farmaceutica S.A. is bioequivalent to the Lexapro ® formulation in regard to both the rate and the extent of absorption. |
| Databáze: | OpenAIRE |
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