Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723238
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2021-01-20
Brief Title:
Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions
Sponsor:
Laboratorios Andromaco SA
Organization:
Laboratorios Andromaco SA
Study Overview
Official Title:
Bioavailability of a Formulation of Duloxetine 60 mg Capsules With Enteric Coated Granules With Regards to the Marketed Reference Product
Status:
COMPLETED
Status Verified Date:
2021-01
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 Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg The Study will be performed at a single site with 36 subjects Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences either test after reference or reference after test There will be a washout of at least 14 days between each study period
Detailed Description:
The primary objective of the study is to investigate the relative bioavailability of Duloxetine of 1 capsule formulation with Duloxetine 60 mg to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption
Test Product Product manufactured by Laboratorios Andrómaco SA
Reference Product CymbaltaTrademark product of Eli Lilly Puerto Rico The 90 confidence intervals for the intra-subject coefficient of variation Test versus Reference Product for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t AUC0-t and from time zero to 72 hours AUC0-72 and maximum plasma concentration Cmax for total Duloxetine will be determined
Participants will be confined in the study site for approximately 255 hours during each study period for 10 hours pre-dosing and for 155 hours post dosing during which pharmacokinetic PK blood samples will be obtained 17 blood samples will be taken up to 24 hours after the administration in each period Participants will return to the site to provide additional blood samples at 48 h and 72 h postdoseThe washout period between the two study periods will be at least 14 days
The samples from each participant will be analyzed with 2 methods of high performance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Duloxetine in plasma
The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events
Test Product Product manufactured by Laboratorios Andrómaco SA
Reference Product CymbaltaTrademark product of Eli Lilly Puerto Rico The 90 confidence intervals for the intra-subject coefficient of variation Test versus Reference Product for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t AUC0-t and from time zero to 72 hours AUC0-72 and maximum plasma concentration Cmax for total Duloxetine will be determined
Participants will be confined in the study site for approximately 255 hours during each study period for 10 hours pre-dosing and for 155 hours post dosing during which pharmacokinetic PK blood samples will be obtained 17 blood samples will be taken up to 24 hours after the administration in each period Participants will return to the site to provide additional blood samples at 48 h and 72 h postdoseThe washout period between the two study periods will be at least 14 days
The samples from each participant will be analyzed with 2 methods of high performance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Duloxetine in plasma
The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None