Atomoxetine hcl 40 mg capsule
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Atomoxetine HCl 40 mg Capsule: Bioequivalence, Pharmacokinetics, and Functional Effects
Bioequivalence of Atomoxetine HCl 40 mg Capsules
Bioequivalence Studies in Healthy Volunteers
A study was conducted to evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (HCl) 40 mg capsules compared to an existing branded version. This randomized, open-label, two-period crossover study involved 22 healthy male Chinese subjects under fasting conditions. Blood samples were collected at various intervals up to 24 hours post-administration, and plasma concentrations were measured using high-performance liquid chromatography (HPLC) with UV detection. The results showed that the 90% confidence intervals for the ratios of atomoxetine for AUC0-24, AUC0-∞, and Cmax were within the acceptable range of 80-125% and 75-133%, indicating that the new formulation is bioequivalent to the reference product.
Pharmacokinetics of Atomoxetine HCl 40 mg Capsules
Pharmacokinetic Parameters in Healthy Volunteers
Another study focused on the pharmacokinetics of atomoxetine HCl 40 mg capsules in 10 healthy volunteers. Blood samples were collected at multiple time points up to 24 hours after a single oral dose. The plasma concentrations were analyzed using a rapid and sensitive HPLC-MS method. The pharmacokinetic parameters revealed that atomoxetine follows a two-compartment model with a half-life (T1/2) of approximately 3.17 hours, a time to reach maximum concentration (Tmax) of about 1.23 hours, and a maximum concentration (Cmax) of 447.28 µg/L. The area under the curve (AUC0-24) was 1959.70 µg·h/L, and AUC0-∞ was 2007.20 µg·h/L, indicating consistent pharmacokinetic characteristics with previous reports.
Functional Effects of Atomoxetine HCl 40 mg Capsules
Impact on Inhibitory Control and Brain Activation
Atomoxetine, a selective noradrenaline reuptake inhibitor (SNRI), is used to treat attention-deficit/hyperactivity disorder (ADHD) by improving response inhibition. A study using a stop-signal functional magnetic resonance imaging (fMRI) paradigm in 19 healthy volunteers examined the effects of a 40 mg dose of atomoxetine. The double-blind, placebo-controlled design revealed that atomoxetine significantly improved inhibitory control and increased activation in the right inferior frontal gyrus during response inhibition tasks. Plasma levels of atomoxetine correlated with activation in this brain region during successful inhibition attempts, suggesting that the drug enhances inhibitory control by modulating right inferior frontal function.
Conclusion
The research on atomoxetine HCl 40 mg capsules demonstrates its bioequivalence to existing formulations, consistent pharmacokinetic properties, and significant functional effects on brain activation related to inhibitory control. These findings support the use of atomoxetine in treating ADHD and potentially other disorders involving inhibitory dysfunction.
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