Pharmacokinetic evaluation of two oral formulations of chlorpromazine in healthy subjects
Hyo-Jin Min1, Jun Gi Hwang2,3, Young-Sim Choi1, Min Kyu Park2,3
1 Cheongju Osong National Advanced Clinical Trial Center, ChungBuk National University Hospital, 2 Department of Clinical Pharmacology, ChungBuk National University College of Medicine, and 3 Department of Clinical Pharmacology and Therapeutics, ChungBuk National University Hospital, Cheongju-si, Republic of Korea
DOI 10.5414/CP204934
Abstract
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 (C<sub>max</sub>) and the area under the plasma concentration–time curve to the last measurable concentration (AUC<sub>last</sub>). 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 C<sub>max</sub> and AUC<sub>last</sub> 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.
Author Details
Authors
Departments
- 1 Cheongju Osong National Advanced Clinical Trial Center, ChungBuk National University Hospital,
- 2 Department of Clinical Pharmacology, ChungBuk National University College of Medicine, and
- 3 Department of Clinical Pharmacology and Therapeutics, ChungBuk National University Hospital, Cheongju-si, Republic of Korea
Address
Min Kyu Park, MD, PhD, Department of Clinical Pharmacology and Therapeutics, ChungBuk National University Hospital, Cheongju-si, Republic of Korea
Email:
[email protected]
Citation
Hyo-Jin Min, Jun Gi Hwang, Young-Sim Choi, and Min Kyu Park.Pharmacokinetic evaluation of two oral formulations of chlorpromazine in healthy subjects
. ; : 0-6. doi: 10.5414/CP204934.
