Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride (NCT02943213) | Clinical Trial Compass
CompletedPhase 1
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
South Africa20 participantsStarted 2016-11
Plain-language 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%
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy males and females, 18 to 65 years (both inclusive) at signing of informed consent.
✓. Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
✓. Body mass not less than 50 kg.
✓. Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
✓. Non-smokers.
✓. Females, if:
✓. Written consent given for participation in the study.
Exclusion criteria
✕. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
✕
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine
Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine
. Current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females.
✕. Consumption of more than 5 cups of coffee (or equivalent amounts of caffeine) per day.
✕. Regular exposure to substances of abuse (other than alcohol) within the past year.
✕. Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
✕. Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 10 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin), whichever is the longer) before administration of IMP in this study, at the discretion of the investigator.
✕. Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
✕. A major illness during the 3 months before commencement of the screening period.