NCT02943213

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cycle Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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%

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-10-24
• Last updated: 2017-11-14
• Results posted: 2017-10-13

Locations

1 site across 1 country: South Africa