Healthy VolunteersPhase 1DiosminNCT07674446
Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study
A Phase 1 study testing Dimotec 1000 mg film-coated tablet and Detralex 1000 mg film-coated tablets in people with Healthy Volunteers, run by Keri Pharma Hungary Kft at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dimotec 1000 mg film-coated tablet and Detralex 1000 mg film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 29 Jun 2026to 29 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
ClinSync Clinical Research Pvt. Ltd.
Hyderabad
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Dimotec 1000 mg film-coated tablet, Detralex 1000 mg film-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimotec 1000 mg film-coated tabletDrug
Also called Diosmin 1000 mg
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.
Detralex 1000 mg film-coated tabletsDrug
Also called Daflon 1000 mg
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.
| Study group | Role | What they receive |
|---|---|---|
| Dimotec 1000 mg (Test) | Experimental | 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. Receives: Drug: Dimotec 1000 mg film-coated tablet |
| Detralex 1000 mg (Reference) | Active comparator | 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. Receives: Drug: Detralex 1000 mg film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide
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.
Measured: 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 outcomes (5)
Maximum Observed Plasma Concentration (Cmax) of Diosmetin-3-O-Glucuronide
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.
Measured: 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
Secondary pharmacokinetic parameter calculated by non-compartmental analysis.
Measured: 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
Analysed using non-parametric Wilcoxon and median tests of treatment effect.
Measured: 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
Secondary pharmacokinetic parameter calculated by non-compartmental analysis.
Measured: 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
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).
Measured: Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start29 Jun 2026
- Primary completion16 Aug 2026
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Four-period, two-sequence, full-replicate crossover design. Sequence 1: T-R-T-R; Sequence 2: R-T-R-T. Washout period of at least 14 days between successive treatments. Total study duration approximately 60 days.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keri Pharma Hungary Kft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharath Reddy A, MBBS, Principal investigator, ClinSync Clinical Research Pvt. Ltd., Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674446
- Sponsor's protocol ID
- BE-024-2025
- Acronym
- Diosmin
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07674446
- Acronym / sponsor ID
- Diosmin / BE-024-2025
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Keri Pharma Hungary KftIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four-period, two-sequence, full-replicate crossover design. Sequence 1: T-R-T-R; Sequence 2: R-T-R-T. Washout period of at least 14 days between successive treatments. Total study duration approximately 60 days.
| Arm | Type | Receives |
|---|---|---|
| Dimotec 1000 mg (Test) | Experimental | Drug: Dimotec 1000 mg film-coated tabletSingle 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. |
| Detralex 1000 mg (Reference) | Active comparator | Drug: Detralex 1000 mg film-coated tabletsSingle 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimotec 1000 mg film-coated tabletAlso: Diosmin 1000 mgDiosmin 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. | Drug | Dimotec 1000 mg (Test) |
| Detralex 1000 mg film-coated tabletsAlso: Daflon 1000 mgDiosmin 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. | Drug | Detralex 1000 mg (Reference) |
Primary outcome
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide
Time frame: 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.
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Diosmetin-3-O-Glucuronide
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharath Reddy A, MBBS principal investigator
ClinSync Clinical Research Pvt. Ltd., Hyderabad, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dimotec 1000 mg film-coated tablet and Detralex 1000 mg film-coated tablets in people with Healthy Volunteers, run by Keri Pharma Hungary Kft at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orsolya Gyurjan, PharmD (+36 52 502 610, info@keri.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.