Dustri Online Services

Search Results

Books: 0	Journals: 1	Articles: 1

Original

Pharmacokinetic evaluation of two oral formulations of chlorpromazine in healthy subjects 

Hyo-Jin Min, Jun Gi Hwang, Young-Sim Choi, and Min Kyu Park

Price
42.00 $

Add to Cart

Price

42.00 $

p. 0 - 6

Abstract

Hyo-Jin Min¹, Jun Gi Hwang²,³, Young-Sim Choi¹, and Min Kyu Park²,³

¹Cheongju Osong National Advanced Clinical Trial Center, ChungBuk National University Hospital, ²Department of Clinical Pharmacology, ChungBuk National University College of Medicine, and ³Department of Clinical Pharmacology and Therapeutics, ChungBuk National University Hospital, Cheongju-si, Republic of Korea
Chlorpromazine is a first-generation antipsychotic agent that exerts its therapeutic effects primarily by antagonizing dopamine D2 receptors. This randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted to evaluate the pharmacokinetic bioequivalence of two oral formulations of chlorpromazine 100 mg: Neomazine tablets (Whan In Pharmaceutical Co., Ltd.) and Chlorpromazine HCl tablets (Myung In Pharmaceutical Co., Ltd.). A total of 70 subjects were randomized, and 61 completed both treatment periods. Blood samples were collected at predefined intervals up to 72 hours post dose to assess pharmacokinetic parameters, including maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve to the last measurable concentration (AUClast). Safety was assessed through monitoring of adverse events (AEs), clinical laboratory tests, vital signs, physical examinations, and 12-lead electrocardiograms. The geometric mean ratios (90% confidence intervals) for Cmax and AUClast were 1.0490 (0.9534 – 1.1542) and 0.9941 (0.9261 – 1.0671), respectively, falling within the accepted bioequivalence range of 0.80 – 1.25. Among the 70 subjects who received at least 1 dose, 116 AEs were reported in 48 individuals; all were mild in intensity and resolved without sequelae, and no serious AEs occurred. These findings confirm the pharmacokinetic bioequivalence and favorable tolerability of the two formulations under fasting conditions in healthy adults and support the use of Neomazine as a therapeutically equivalent and clinically interchangeable alternative to Chlorpromazine HCl. Correspondence to:
Min Kyu Park, MD, PhD, Department of Clinical Pharmacology and Therapeutics, ChungBuk National University Hospital, Cheongju-si, Republic of Korea
Email: [email protected]

Shopping Overview

Shopping Overview
Type	Qtty	Discount	VAT	Price
Your basket is empty

View Cart

Search Results

Shopping Overview

Send us an E-Mail