Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT05158192
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product
Sponsor:
Laboratorios Andromaco S.A.
Organization:
Study Overview
Official Title:
Bioavailability of a Formulation of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to the Marketed Reference Product
Status:
COMPLETED
Status Verified Date:
2021-11
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 Pilot study investigated the bioavailability in adult human subjects of 1 tablet formulations containing Diosmin/Hesperidin (90/10) 500 mg. The Pilot study was performed at a single site with 12 subjects. Participants took 1 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There was a washout of 7 days between each study period.
Detailed Description:
The primary objective of the study is to investigate the relative bioavailability of
Diosmin/Hesperidin (90/10) of 1 tablet formulations with Diosmin/Hesperidin (90/10) 500 mg to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
* Test Product: Product manufactured by Laboratorios Andrómaco S.A.
* Reference Product: Daflon \[Trademark\], product of Les Laboratoires Servier, France.
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 infinite (AUC0-inf), and maximum plasma concentration (Cmax) for total metabolite Diosmetin and Hesperetin was determined. Participants were confined in the study site for approximately 42 hours during each study period (for 10 hours pre-dosing and for 32 hours post dosing) during which pharmacokinetic (PK) blood samples were obtained. 21 blood samples were taken up to 32 hours after the administration in each period. Participants returned to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods was 7days. The samples from each participant were analyzed with validated LC-MS/MS method used for estimation of Diosmetin and Hesperetin in plasma.
The safety objective was to evaluate the tolerability of both formulations in subjects by collecting adverse events.
Diosmin/Hesperidin (90/10) of 1 tablet formulations with Diosmin/Hesperidin (90/10) 500 mg to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
* Test Product: Product manufactured by Laboratorios Andrómaco S.A.
* Reference Product: Daflon \[Trademark\], product of Les Laboratoires Servier, France.
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 infinite (AUC0-inf), and maximum plasma concentration (Cmax) for total metabolite Diosmetin and Hesperetin was determined. Participants were confined in the study site for approximately 42 hours during each study period (for 10 hours pre-dosing and for 32 hours post dosing) during which pharmacokinetic (PK) blood samples were obtained. 21 blood samples were taken up to 32 hours after the administration in each period. Participants returned to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods was 7days. The samples from each participant were analyzed with validated LC-MS/MS method used for estimation of Diosmetin and Hesperetin in plasma.
The safety objective was to evaluate the tolerability of both formulations in subjects by collecting adverse events.
Study Oversight
Has Oversight DMC:
False
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?: