Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study (Diosmin)
2026年9月7日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
72
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Orsolya Gyurjan, PharmD
- 電話番号：+36 52 502 610
- メール：info@keri.hu
研究場所
-
-
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Hyderabad、インド
- 募集
- ClinSync Clinical Research Pvt. Ltd.
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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アクティブコンパレータ：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Diosmetin-3-O-Glucuronide
時間枠：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
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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.
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of Diosmetin-3-O-Glucuronide
時間枠：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
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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
|
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Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Diosmetin-3-O-Glucuronide
時間枠：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
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Secondary pharmacokinetic parameter calculated by non-compartmental analysis.
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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
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Time to Maximum Plasma Concentration (Tmax) of Diosmetin-3-O-Glucuronide
時間枠：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
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Analysed using non-parametric Wilcoxon and median tests of treatment effect.
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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
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Apparent First-Order Terminal Elimination Half-Life (t1/2) of Diosmetin-3-O-Glucuronide
時間枠：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.
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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
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Incidence of Adverse Events
時間枠：Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
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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).
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Throughout the study, from check-in to 72 hours post-dose in each period (approximately 60 days total)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Sharath Reddy A, MBBS、ClinSync Clinical Research Pvt. Ltd., Hyderabad, India
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月29日
一次修了 (実際)
2026年8月16日
研究の完了 (推定)
2026年12月29日
試験登録日
最初に提出
2026年6月23日
QC基準を満たした最初の提出物
2026年6月23日
最初の投稿 (実際)
2026年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BE-024-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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