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治験 NCT06519604（対象：糖尿病）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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上海交通大学Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males 第I相・フェーズ1 20 無作為化 クロスオーバー法
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治験番号 NCT06519604 は 糖尿病 に関する 治療 の研究で、第I相・フェーズ1 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2024年7月17日 から開始しています。20 名の参加者 の募集が計画されています。この試験は 上海交通大学 によって主導され、2025年10月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年5月16日 です。
概要
Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU
詳細説明
An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic euglycemic clamp.
公式タイトル
An Open, Randomized, Single Dose, Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects
疾患名
糖尿病その他の研究識別子
- ORA-H-CN-007
NCT番号
開始日
2024-07-17
最終更新日
2025-05-16
終了予定日
2025-10-30
目標参加者数
20
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
状況
実施中／登録終了
主目的
治療
割付方法
無作為化
介入モデル
クロスオーバー法
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Human insulin enteric coated capsules in dose 16mg Single oral administration of human insulin enteric coated capsules in dose 16mg. | Human insulin enteric coated capsules in dose 16mg Single oral administration of human insulin enteric coated capsules in dose 16mg |
実験的Human insulin enteric coated capsules in dose 8mg Single oral administration of human insulin enteric coated capsules in dose 8mg | Human insulin enteric coated capsules in dose 8mg Single oral administration of human insulin enteric coated capsules in dose 16mg |
実薬対照薬Human Insulin Injection in dose 5IU Single subcutaneous administration of Human Insulin Injection in dose 5IU | Human Insulin Injection in dose 5IU Single subcutaneous administration of Human Insulin Injection in dose 5IU |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
GIRmax | PD endpoint: The maximum glucose infusion rate | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
TGIRmax | PD endpoint: The time to maximum observed glucose infusion rate | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCGIR.0-11h | PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCGIR0-∞ | PD endpoint: The area under the glucose infusion rate curve from 0 to infinity | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Cmax | PK endpoint: The maximum observed insulin concentration | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
Tmax | PK endpoint: The time to maximum observed insulin concentration | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCIns0-11h | PK endpoint: The area under the insulin concentration curve from 0 to 11 hours | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCIns0-∞ | PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
参加アシスタント
適格基準
対象年齢
成人
試験の最低年齢
20 Years
対象性別
男性
健康なボランティアを受け入れる
はい
- Healthy Chinese male subjects aged 20-35 (inclusive);
- Body mass index (BMI) between19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
- Normal oral glucose tolerance Test (fasting plasma glucose \[FPG\]< 6.1 mmol/L and 2-hour postprandial blood glucose after loading with glucose \[2hPG\]< 7.8 mmol/L), and HbA1C<6.0%
- Normal insulin releasing test (judged by investigator);
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, without history of acute and chronic diseases with clinical significance, incl.: of the cardiovascular system, bronchopulmonary, neuroendocrine systems, endocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, as judged by the Investigator.
- Signed informed consent and volunteers' consent to all restrictions imposed during the study.
- Known allergic or suspected hypersensitivity to investigational product (IP) or related product
- Previous or existing diseases of the cardiovascular system, endocrine system, gastrointestinal system, nervous system, or diseases of the lungs, hematologic, immunology, psychiatry, and metabolic abnormalities, as judged by the investigator;
- History of heavy smoking, alcohol abuse, and drug abuse;
- Taking more than 14 units alcohol per week within 3 months prior to screening (1unit≈360 mL of beer, 45mL of spirits, or 150 mL of wine), or receiving alcohol within 48 hours prior to IP administration, or failure to abstain from alcohol during the trial ;
- Receiving excessive amounts of tea, coffee, and/or caffeine rich beverages (8 or more cups, 1 cup ≈ 250 mL) per day within 3 months prior to screening;
- Use of any medication that may affect glucose lowering effect (such as oral contraceptives, corticosteroids, diuretics, adrenaline, salbutamol, glucagon, growth hormone, thyroid hormone, etc.) within 28 days prior to screening;
- Taking any medications, vitamin product, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;
- Participation in any clinical trial less than 3 months prior to screening or plan to participate in other trials after ICF signed.
- Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; blood transfusion or component blood transfusion within 3 months prior to screening; failure to guarantee not to donate whole blood / component blood (such as plasma, platelets) during the trial or within 30 days after the end of the trial;
- Undergo surgery prior to IP administration within 1 month or plan to undergo surgery during the trial;
- Occurrence of acute disease during screening;
- Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TPAb;
- history of needle phobia and blood phobia;
- Any conditions that make volunteer participation is ineligible judged by investigating physician.
上海交通大学327 件のアクティブな治験を探索責任者
Wang Weiqing, 主任研究者, Professor, PHD, MD, Shanghai Jiao Tong University School of Medicine
連絡先情報がありません。
1 1カ国の場所
Shanghai Municipality
uijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, 200025, China