A Phase 1 interventional study of Diosmin/Hesperidin (90/10) 500 mg Test Drug and Diosmin/Hesperidin (90/10) 500 mg Reference Product in Bioequivalence, sponsored by Laboratorios Andromaco S.A.. Completed at 1 site in India. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-14.
Sponsored by Laboratorios Andromaco S.A. · Phase 1, Interventional, and Basic science
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.
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:
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.
Laboratorios Andromaco S.A. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received one tablet of the test formulation containing Diosmin/Hesperidin (90/10) 500 mg. The tablets was taken with water and in a fasting condition.
Drug: Diosmin/Hesperidin (90/10) 500 mg Test Drug
Participants received one tablet of the marketed reference formulation containing Diosmin/Hesperidin (90/10) 500 mg. The tablets was taken with water and in a fasting condition.
Drug: Diosmin/Hesperidin (90/10) 500 mg Reference Product
Investigational Medicinal Product
Daflon (Trademark)
Total Diosmin/Hesperidin (90/10): area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
23 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Diosmin/Hesperidin (90/10): area under the plasma concentration-time curve from 0 to t hours (AUC0-t)
23 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Diosmin/Hesperidin (90/10): Maximum plasma concentration (Cmax)
23 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Laboratorios Andromaco S.A.