Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product

NCT05158192 | Completed Phase 1

• 1 other identifier: HP8834-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From tablet intake and up to 72 hours after tablet intake

Study Arms (2)

Diosmin/Hesperidin (90/10) Test Product

EXPERIMENTAL

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

Diosmin/Hesperidin (90/10) Reference Product

ACTIVE COMPARATOR

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

Interventions

Diosmin/Hesperidin (90/10) 500 mg Test Drug DRUG

Investigational Medicinal Product

Diosmin/Hesperidin (90/10) Test Product

Diosmin/Hesperidin (90/10) 500 mg Reference Product DRUG

Daflon (Trademark)

Diosmin/Hesperidin (90/10) Reference Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg.
• Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• Normal or clinically insignificant ECG.
• Negative urine test for drugs of abuse for both males and females and negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study.
• Volunteers who are willing to use acceptable methods of contraception (barrier method/IUD/surgical) or abstinence, for the entire duration of the study and do not plan to be pregnant for atleast 1 month after the last drug administration.
• Volunteers who can give written informed consent and communicate effectively.

You may not qualify if:

• History of any major surgical procedure in the past 03 months.
• History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• History of chronic alcoholism/ chronic smoking/ drug of abuse.
• Volunteers with known hypersensitivity to Diosmin/Hesperidin or any of the excipients.
• History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
• Volunteers who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Diosmin/Hesperidin or any other medication judged to be clinically significant by the investigator.
• History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• Volunteers who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator
• Volunteers who are dysphagic.

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Azidus Laboratories Ltd.

Chennai, Tamil Nadu, 600048, India

Location

MeSH Terms

Interventions

Diosmin; Hesperidin; Drug Evaluation

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: November 4, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: February 14, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)