Pharmacokinetic evaluation of two oral formulations of chlorpromazine in healthy subjects.

In 30 seconds

This randomized controlled trial evaluated the pharmacokinetic bioequivalence of two oral formulations of chlorpromazine (100 mg) in healthy subjects. A total of 61 participants completed the study, showing geometric mean ratios for maximum plasma concentration (C max) and area under the curve (AUC last) of 1.0490 and 0.9941, respectively, both within the bioequivalence range of 0.80-1.25.

Key findings

• Geometric mean ratio for C max was 1.0490 (90% CI: 0.9534-1.1542).
• Geometric mean ratio for AUC last was 0.9941 (90% CI: 0.9261-1.0671).
• 116 adverse events were reported, all mild and resolved without sequelae.
• No serious adverse events occurred during the study.

Why it matters

Understanding the bioequivalence of different formulations of chlorpromazine is crucial for ensuring consistent therapeutic outcomes in patients. This study supports the use of Neomazine as a clinically interchangeable option.