Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study (Diosmin)
23. juni 2026 opdateret af: Keri Pharma Hungary Kft
Comparative Bioavailability Study of Dimotec 1000 mg Film-coated Tablet Versus Detralex 1000 mg Film Coated Tablets in Healthy Subjects Under Fed Conditions: Randomized, Four-period, Full-replicate Crossover
This study aims to compare the bioavailability of Dimotec 1000 mg film-coated tablet (Test; Keri Pharma Hungary Kft.) with Detralex 1000 mg film-coated tablets (Reference; Les Laboratoires Servier Industrie, France) in healthy adult human participants under fed conditions.
The study will also evaluate the safety and tolerability of a single dose of the investigational products.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is an open-label, balanced, randomized, single-dose, two-treatment, two-sequence, four-period, full-replicate, crossover, comparative bioavailability study conducted in healthy adult human participants under fed conditions.
A total of 72 participants will be enrolled (with up to 6 stand-by participants), targeting 64 completers. Participants will receive a single oral dose of either the Test product (Dimotec 1000 mg film-coated tablet) or Reference product (Detralex 1000 mg film-coated tablets) following an overnight fast of at least 10 hours and 30 minutes after consumption of a high-fat, high-calorie non-vegetarian breakfast (approximately 967 kcal; approximately 57.5% fat, 26.8% carbohydrate, 15.7% protein).
The study comprises four periods with a washout of at least 14 days between successive doses. Participants are housed for at least 60 hours pre-dose and up to 72 hours post-dose in each period.
Pharmacokinetic blood samples (4 mL each) are collected at 25 time points per period: pre-dose (-1.25, -1.00, -0.75 h) and post-dose at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours. Plasma samples are assayed for diosmetin-3-O-glucuronide using a validated bioanalytical method.
Primary PK parameters: Cmax and AUC0-t. Secondary PK parameters: AUC0-inf, Tmax, t1/2, Kel, and Residual area.
Statistical analysis will be performed using SAS v9.4 or higher. ANOVA on ln-transformed Cmax and AUC0-t; 90% confidence intervals for the Test/Reference geometric least square mean ratio must fall within 80.00-125.00%. Reference-scaled average bioequivalence will be applied for Cmax if within-subject CV of the Reference exceeds 30%, with widened limits up to 69.84-143.19%.
The study is conducted at ClinSync Clinical Research Pvt. Ltd., Hyderabad, India.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
72
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Orsolya Gyurjan, PharmD
- Telefonnummer: +36 52 502 610
- E-mail: info@keri.hu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Healthy adult human participants aged 18 to 55 years (inclusive)
- BMI between 18.50 and 30.00 kg/m2 (inclusive), capable of giving informed consent
- Normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests during screening within 28 days of enrollment
- Normal 12-lead electrocardiogram (ECG)
- Normal chest X-Ray (P/A view) taken not more than 180 days prior to check-in of Period 1
- Non-smoker or ex-smoker who stopped smoking at least 6 months before first dosing
- Non-alcoholic
- Female participants of childbearing potential must practice a medically acceptable method of contraception (double barrier, IUD, or abstinence); females with no childbearing potential defined as surgically sterile or post-menopausal for at least 1 year
Exclusion Criteria:
- Contraindications or hypersensitivity to the study drug, related drug group, or excipients
- History or presence of significant asthma, urticaria, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological, psychiatric, endocrine, immunological, hematopoietic, diarrheal, or ongoing infectious diseases, or any other significant abnormality
- History or presence of gastrointestinal inflammation, bleeding, ulceration, hemorrhage, or perforation of the stomach, small intestine, or large intestine
- History of dermatological diseases (skin reactions, skin rash) related to drug use, or presence of any dermatological diseases
- Unable to swallow large-size tablets
- Use of any food supplements containing flavonoids within 14 days before first dosing or during the study
- Blood donation (500 mL) or participation in any clinical study within 90 days prior to check-in
- Use of any prescribed medications, OTC medications, or herbal medications within 30 days prior to first dose
- Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids, barbiturates) in urine at check-in
- Positive urine/breath alcohol test at check-in
- Positive pregnancy test
- Currently pregnant, breast-feeding, or likely to become pregnant during the study
- Use of implanted or injected hormonal contraceptives within 6 months prior to study, or hormonal contraceptives within 14 days before dosing
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Dimotec 1000 mg (Test)
Single oral dose of Dimotec 1000 mg film-coated tablet (Test product; Keri Pharma Hungary Kft., manufactured by MEDITOP Gyogyszeripari Kft.) administered under fed conditions (30 minutes after a high-fat, high-calorie breakfast) with approximately 240 mL of water, in sitting upright posture.
|
Diosmin 1000 mg film-coated tablet.
Single oral dose administered under fed conditions.
Active substance: Diosmin 1000 mg.
ATC code: C05CA03.
Manufactured by MEDITOP Gyogyszeripari Kft., Hungary.
Marketing Authorisation Holder: Keri Pharma Hungary Kft.
Andre navne:
|
|
Aktiv komparator: Detralex 1000 mg (Reference)
Single oral dose of Detralex 1000 mg film-coated tablets (Reference product; Les Laboratoires Servier Industrie, France, manufactured by Servier (Ireland) Industries Ltd.) administered under fed conditions (30 minutes after a high-fat, high-calorie breakfast) with approximately 240 mL of water, in sitting upright posture.
|
Diosmin 1000 mg film-coated tablets.
Single oral dose administered under fed conditions.
Active substance: Diosmin 1000 mg.
ATC code: C05CA53.
Manufactured by Servier (Ireland) Industries Ltd. Marketing Authorisation Holder: Les Laboratoires Servier Industrie, France.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide
Tidsramme: Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
AUC0-t calculated using the linear trapezoidal method.
The 90% confidence interval of the geometric least square mean ratio (Test/Reference) must fall within 80.00-125.00% to establish bioequivalence.
|
Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Diosmetin-3-O-Glucuronide
Tidsramme: Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
The 90% CI of the geometric least square mean ratio (T/R) must be within 80.00-125.00%.
Reference-scaled widening (up to 69.84-143.19%)
applies if within-subject CV of the Reference is 30% or above.
|
Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
|
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Diosmetin-3-O-Glucuronide
Tidsramme: Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
Secondary pharmacokinetic parameter calculated by non-compartmental analysis.
|
Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
|
Time to Maximum Plasma Concentration (Tmax) of Diosmetin-3-O-Glucuronide
Tidsramme: Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
Analysed using non-parametric Wilcoxon and median tests of treatment effect.
|
Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
|
Apparent First-Order Terminal Elimination Half-Life (t1/2) of Diosmetin-3-O-Glucuronide
Tidsramme: Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
Secondary pharmacokinetic parameter calculated by non-compartmental analysis.
|
Pre-dose and at 1, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 29, 34, 40, 48, 60, and 72 hours post-dose
|
|
Incidence of Adverse Events
Tidsramme: Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
|
Safety assessments include vital signs (blood pressure, pulse rate, respiratory rate, body temperature), participant well-being monitoring, laboratory evaluations (haematology and biochemistry), and recording of adverse events graded by severity (Grades 1-5).
|
Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sharath Reddy A, MBBS, ClinSync Clinical Research Pvt. Ltd., Hyderabad, India
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
29. juni 2026
Primær færdiggørelse (Anslået)
27. august 2026
Studieafslutning (Anslået)
27. august 2026
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BE-024-2025
Plan for individuelle deltagerdata (IPD)
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