NDLI: Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Nam, Yunsung Lim, Cheol-Hee Lee, Ho Sung Chung, Su Jin Chung, Yoon Hee Shin, Yong Kyoo Kim, Min-Gul Sohn, Uy Dong Kim, Hyoung-Chun Jeong, Ji Hoon
Spatial Coverage	Republic of Korea
Description	Author Affiliation: Nam Y ( Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea.); Lim CH ( Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea.); Lee HS ( Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea.); Chung SJ ( Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea.); Chung YH ( Department of Anatomy, College of Medicine, Chung-ang University, Seoul, Republic of Korea.); Shin YK ( Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea.); Kim MG ( Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.); Sohn UD ( Department of pharmacology, College of Pharmacy, Chung-ang University, Seoul, Republic of Korea.); Kim HC ( Neuropsychopharmacology & Toxicology Program, College of Pharmacy, Kangwon National University, Chunchon, Republic of Korea.); Jeong JH ( Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea. Electronic address: jhjeong3@cau.ac.kr.)
Abstract	PURPOSE: Amitriptyline is the most widely used tricyclic antidepressant (TCA). Although amitriptyline hydrochloride 10 and 25 mg has been marketed in Korea, no data on the dose proportionality of amitriptyline in Korean subjects are available. This clinical trial was designed to evaluate and compare the relative bioavailability with regard to dose proportionality between the two marketed strengths of amitriptyline hydrochloride tablets after a single-dose, oral administration under fasting conditions in healthy, male, Korean volunteers. METHODS: This single-dose, randomized, open-label, 2-way crossover study was conducted in healthy male Korean subjects. Subjects were randomly assigned to 1 of 2 dose groups and received a single dose of 10 or 25 mg amitriptyline hydrochloride under fasting conditions, followed by the alternate dose in the subsequent study period. High performance liquid chromatography (HPLC)-mass spectrometry (MS)/MS detection was applied to determine plasma concentrations. Pharmacokinetic parameters were calculated, C(max), AUC(last), AUC(0-∞), t(½), and T(max). Statistical analysis was performed for the assessment of dose proportionality. Tolerability was assessed for up to 96 hours after administration. FINDINGS: Twelve healthy Korean subjects completed this trial (mean [SD] age, 21.7 [1.9] years; height, 174.5 [5.0] cm; and weight, 66.7 [9.4] kg). Although 4 subjects experienced a total 5 adverse events (AEs), no serious AEs were reported during the study. The mean values of C(max) and AUC were proportional to the doses of 10 and 25 mg. The C(max), AUC(last), and AUC(0-∞) of amitriptyline hydrochloride 10 mg were 5.96 ng/mL, 91.35 ng·h/mL and 109.74 ng·h/mL, respectively. The C(max), AUC(last), and AUC(0-∞) of amitriptyline hydrochloride 25 mg were 17.69 ng/mL, 260.68 ng·h/mL, and 296.87 ng·h/mL, respectively. IMPLICATIONS: Our results suggest that the 2 strengths of amitriptyline hydrochloride (10 and 25 mg) exhibited linear (dose-dependent) pharmacokinetics in these healthy, male, Korean subjects. Based on these results, a predictable and linear increase in systemic exposure can be expected. ClinicalTrials.gov identifier: NCT01367080.
File Format	HTM / HTML
ISSN	01492918
Issue Number	2
Volume Number	37
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2015-02-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Amitriptyline Pharmacokinetics Antidepressive Agents, Tricyclic Administration, Oral Adult Administration & Dosage Adverse Effects Area Under Curve Asian Continental Ancestry Group Biological Availability Chromatography, High Pressure Liquid Cross-over Studies Fasting Metabolism Healthy Volunteers Humans Male Republic Of Korea Tablets Tandem Mass Spectrometry Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers.

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