Subjects who used any drugs within 2 weeks before the first administration of amitriptyline hydrochloride, female subjects who were pregnant or lactating during the study, and subjects who suffered from any condition which could possibly affect the absorption of the drug were also excluded.This study (ClinicalTrials.gov, NCT03646526) was performed at the Phase I Clinical Research Center of the First Affiliated Hospital, College of Medicine, Zhejiang University, China, in accordance with the Declaration of Helsinki, the Good Clinical Practice Guidelines of the International Conference on Harmonization, and other related guidelines. Bioequivalence was established considering the CUnder fasting and fed conditions, nortriptyline AUCThe pharmacokinetic parameters of amitriptyline in this study were compared with those previously reported.The pharmacokinetic difference between the parameters of this study and previous studies maybe influenced by different drugs’ manufacturers.Furthermore, pharmacokinetic data under fasting and fed conditions were compared. human studies with clinical or 90 pharmacodynamic end points, studies using animal models or in vitro studies as long as they 91 are appropriately justified and/or validated. Data were acquired with the analyst software, version 1.6.3. Water intake within 1 h before and after dosing was prohibited. No other study-related document will be made available.Hunan Dongting Pharmaceutical Co., Ltd. (Hunan, China) funded our study, which was the manufacturer of amitriptyline hydrochloride tablets. The cleaning period is 21 ± 1 day.Based on the results of the first part of the pre-test evaluation, the experimental design and sampling time and other contents of the second part of the formal test may require necessary modifications.The fasting test and the postprandial test in the formal test were carried out independently.During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under fasting condition .cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under feeding condition.cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）Male volunteers must take effective and appropriate 14 days before dosing until 6 months after the end of the study.The contraceptive measures and agrees not to perform sperm donation within six months from the administration until the end of the study;Fully understand the purpose of the test, the nature of the test, the study procedures, and possible adverse reactions.Willing to participate in the trial and sign the informed consent form (the process of obtaining the informed consent accords with GCP regulations); The World Health Organization (WHO) estimates that depression is the leading cause of disability and results in high morbidity, high suicide rates, and low clinical treatment rates worldwide.Amitriptyline, the most commonly used TCA, has a strong sedative effect and is primarily used to treat anxiety or agitated depression. Elle s'utilise pour soigner une dépression. Standard lunches and dinners were provided at the same time for both groups of the study, at 4 and 10 h after dosing.A series of blood samples were collected before and after each treatment period. This study was conducted under both fasting and fed conditions, in healthy Chinese volunteers. A thorough oral examination was performed after each drug administration to confirm oral film dissolution. All authors report no conflicts of interest in this work.The opinions expressed in all articles published here are those of the specific author(s), and do not necessarily reflect the views of Dove Medical Press Ltd or any of its employees.Dove Medical Press is part of Taylor & Francis Group, the Academic Publishing Division of Informa PLC
Furthermore, it is slightly more effective than other TCAs or newer compounds.During amitriptyline metabolism, its side chain oxidizes producing a secondary amine nortriptyline, an N-oxide amitriptylinoxide (AT-NO), and a primary amine.Although amitriptyline hydrochloride has been widely used in China for several years, only a limited number of reports have studied its efficacy and tolerability during treatment of depressive disorders or other diseases. In the fed study, 86 AEs were recorded in 24 subjects taking the test and reference products. L'amitriptyline appartient à la famille des médicaments appelés antidépresseurs tricycliques.