Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride

Acute Intermittent Porphyria Clinical Trial

Official title: A Single Center, Single Dose, Open-Label, Two-Period Replicate Pilot Study to Investigate Intra-subject Variability in the Bioavailability of a Formulation Containing Chlorpromazine Hydrochloride (25 mg Sugar Coated Tablets) in at Least 16 Healthy Males and Females Under Fasting Conditions

Status Completed

Clinical Trial Summary

Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.

The aim of this pilot study is to investigate intrasubject variability in the bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.

Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve and a wide safety margin. This will then allow for the modification of bioequivalence acceptance criteria in future pivotal studies which will reduce the number of participants required whilst still maintaining assurance of safety and efficacy.

Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine; 7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%

Clinical Trial Description

This will be a single-dose, open-label, two-period replicate pilot study with orally administered chlorpromazine hydrochloride 25 mg (sugar coated tablets) conducted under fasting conditions in at least 16 healthy male and female subjects at a single study center.

Up to 20 eligible subjects will be enrolled in the study with 16 evaluable subjects to complete the study.

Analytes to be measured will be Chlorpromazine and 7-hydroxy-Chlorpromazine (free) as stipulated by FDA Guidance for assessment of bioequivalence for Chlorpromazine. ;

Related Conditions & MeSH terms

• Acute Intermittent Porphyria
• Adjunct in the Treatment of Tetanus
• Anti-Psychotic
• Control Manifestations of the Manic Type of Mani-depressive Illness
• Control Nausea and Vomiting
• Depression
• Depressive Disorder
• Management of Manifestations of Psychotic Disorders
• Mental Disorders
• Porphyria, Acute Intermittent
• Porphyrias
• Psychomotor Agitation
• Psychotic Disorders
• Relief of Intractable Hiccups
• Relief of Restlessness and Apprehension Before Surgery
• Schizophrenia
• Treatment of Schizophrenia
• Vomiting

• NCT number: NCT02943213
• Study type: Interventional
• Source: Cycle Pharmaceuticals Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: November 2016
• Completion date: December 2016