Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01121913
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2010-05-10
Brief Title:
Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers
Sponsor:
Labopharm Inc
Organization:
Labopharm Inc
Study Overview
Official Title:
A Randomized Four-way Crossover Pilot Study to Compare the Relative Bioavailability of Two Prototype Once-a-day Trazodone Hydrochloride Products and Two Marketed Reference Products Following an Equivalent Daily Dose Administration Under Fasting Conditions in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2012-04
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:
The objectives of this study were
to compare the pharmacokinetic profiles of two prototype controlled-release CR trazodone hydrochloride HCl 300 mg tablets versus two reference products Trittico AC 2 x 150 mg CR tablets and Desyrel 3 x 100 mg IR immediate-release tablets under fasting condition
to assess the controlled release properties of the two prototype formulations
to select a prototype formulation for further development
to validate the blood sampling schedule for future pivotal pharmacokinetic studies
to determine the appropriate sample size for pivotal studies based in the intra-subject variability
to compare the pharmacokinetic profiles of two prototype controlled-release CR trazodone hydrochloride HCl 300 mg tablets versus two reference products Trittico AC 2 x 150 mg CR tablets and Desyrel 3 x 100 mg IR immediate-release tablets under fasting condition
to assess the controlled release properties of the two prototype formulations
to select a prototype formulation for further development
to validate the blood sampling schedule for future pivotal pharmacokinetic studies
to determine the appropriate sample size for pivotal studies based in the intra-subject variability
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?:
None