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

Launched by LABORATORIOS ANDROMACO S.A. · Dec 2, 2021

Keywords

ClinConnect Summary

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 plasm...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• • 3. Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• • 4. Normal or clinically insignificant ECG.
• • 5. 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.
• • 6. 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.
• • 7. Volunteers who can give written informed consent and communicate effectively.
• Exclusion Criteria:
• • 1. History of any major surgical procedure in the past 03 months.
• • 2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• • 3. History of chronic alcoholism/ chronic smoking/ drug of abuse.
• • 4. Volunteers with known hypersensitivity to Diosmin/Hesperidin or any of the excipients.
• • 5. History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
• • 6. Volunteers who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• • 7. 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.
• • 8. History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• • 9. Volunteers who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• • 10. 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
• • 11. Volunteers who are dysphagic.