Finding studies
Finding studies
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Lead
Cycle Pharmaceuticals Ltd.
With
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
