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
Keywords: Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride Bioavailability Variability Variable Absorption USL Pharma USL Healthy South Africa Cycle Anti-Psychotic
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: First dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet. arm 2: Second dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.

Interventions: intervention 1: Chlorpromazine Hydrochloride
Intervention descriptions: intervention 1: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

Protocol document: