Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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%