Relative Bioequivalence Evaluation of Two Oral Atomoxetine Hydrochloride Capsules: A Single Dose, Randomized, Open-Label, 2-Period Crossover Study in Healthy Chinese Volunteers under Fasting Conditions

D.-W. Shang; W. Guo; F.-C. Zhou; X.-P. Wang; A.-N. Li; L. Zhang; W.-B. Li; W. Lu; C.-Y. Wang

doi:10.1055/s-0033-1349070

Drug Research, Table of Contents

Drug Res (Stuttg) 2013; 63(11): 564-567
DOI: 10.1055/s-0033-1349070

Original Article

Relative Bioequivalence Evaluation of Two Oral Atomoxetine Hydrochloride Capsules: A Single Dose, Randomized, Open-Label, 2-Period Crossover Study in Healthy Chinese Volunteers under Fasting Conditions

D.-W. Shang

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

²Department of Pharmacy, Guangzhou Brain Hospital, Guangzhou Medical University, Guangzhou, China

,

W. Guo

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

,

F.-C. Zhou

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

,

X.-P. Wang

³Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China

,

A.-N. Li

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

,

L. Zhang

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

,

W.-B. Li

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

,

W. Lu

⁴Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China

,

C.-Y. Wang

¹Beijing Key Lab of Diagnostics and Therapeutics for Psychiatic disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China

⁵Beijing Key Lab of Brain Major Disorders – State Key Lab Incubation Base, Capital Medical University, Beijing, China

⁶Beijing Neuroscience Disciplines, Capital Medical University, Beijing, China

› Author Affiliations

Abstract

To evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (CAS 82248-59-7) capsules (test) and an available branded capsules (reference) after administration of a single 40 mg dose, randomized, open-label, 2-period crossover study was conducted in 22 healthy male Chinese subjects with a 1-week wash-out period. This study was designed for/the Honglin Pharmaceutical Co. Ltd and contracted to be done by the Beijing Anding Hospital in order to satisfy Chinese regulatory requirements to allow marketing of this generic product and performed according to the criteria of SFDA. Blood samples were collected before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and 24 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detection. A non-compartmental method was used to calculate the pharmacokinetic parameters and evaluate bioequivalence of the 2 formulations. The 90% confidence interval (CI) of the ratios (test/reference) of atomoxetine for AUC_0–24, AUC_0–∞ and C_max were 100.9% (93.6–108.8%), 103.1% (95.1–111.7%) and 105.2% (92.8–119.4%), respectively, which fell within the interval of 80–125% and 75–133%. No clinically significant changes or abnormalities were noted in laboratory data and vital signs. From these results it can be concluded that the test formulation of atomoxetine capsules met the regulatory criterion for bioequivalence to the reference formulation.

Key words

atomoxetine - pharmacokinetics - bioequivalence - CAS 82248-59-7

Full Text

References

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