Ignite Creation Date:
2025-12-18 @ 9:48 AM
Ignite Modification Date:
2025-12-23 @ 9:19 PM
Study NCT ID:
NCT02943213
Status:
None
Last Update Posted:
2017-11-14 00:00:00
First Post:
2016-10-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Sponsor:
None
Organization:
Study Overview
Official Title:
A Single Center, Single Dose, Open-Label, Two-Period Replicate Pilot Study to Investigate Intra-subject Variability in the Bioavailability of a Formulation Containing Chlorpromazine Hydrochloride (25 mg Sugar Coated Tablets) in at Least 16 Healthy Males and Females Under Fasting Conditions
Status:
None
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: