MedTrace Logo

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

NCT02943213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-11-14

Study results available
· View outcomes & findings →

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%

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

DRUG

Chlorpromazine Hydrochloride

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Cycle Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Yolandi Swart, FCPHM(SA) · Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02943213 on ClinicalTrials.gov