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A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)

2026年9月15日 更新者:Triastek (Shanghai) Limited

A Phase 1, Single-center, Open-Label, Randomized, Three-Period, Six-Sequence, Single-Dose, Crossover Study in Healthy Participants Under Fasted or Fed Condition to Compare the Relative Bioavailability of Orally Administrated Octreotide Acetate Tablets (T25) and Orally Administrated Octreotide Acetate Delayed-Release Capsules (MYCAPSSA®) and to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25

The goal of this clinical trial] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are:

  1. How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa?
  2. What effects does of food have on the pharmacokinetic profile of T25 when administerted under high fat diet?

Participants will:

Take T25 under both fast and food state or mycapssa in under fast state in Day1, Day4, and Day7, 13. A follow-up visit is scheduled on D14+(7), which is 7~14 days after the last dose of investigational product via phone/message/WeChat or in face-to-face manner.

調査の概要

研究の種類

介入

入学 (実際)

18

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。

研究場所

    • Shandong
      • Zibo、Shandong、中国
        • Zibo Central Hospital

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:

  1. Healthy male or female aged 18 to 55 years (both inclusive).
  2. Participants with a body mass index (BMI, weight [kg]/height2 [m2]) within 19-28 kg/m2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female.
  3. Participants with good physical condition, without any history of disease or clinically relevantly abnormal vital signs or physical examination. Participants in good general health, without clinically significant physical examination, vital signs, laboratory tests, ECGs, or abdominal ultrasound findings at Screening or Check-in (Day -2) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
  4. Participants with childbearing potential must agree to use adequate contraception and have no plan for pregnancy from screening period throughout 3 months after the last dose of investigational product; Women of childbearing potential (WOCBP) must have a negative blood pregnancy test prior to the first dose of investigational products. Note: WOCBP are defined as females who have reached menarche but have not yet undergone menopause (defined as ≥12 consecutive months of amenorrhea for non-pathological reasons) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
  5. Participants must fully understand and voluntarily sign the informed consent form prior to the initiation of any study procedures.
  6. Participants with high compliance for all protocol requirements.

Exclusion Criteria:

  1. Participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage.
  2. Participants with positive for human immunodeficiency virus (HIV) antibody test; active infection with Hepatitis B, C; positive treponema pallidum antibody test.
  3. Participants with a history of chronic or severe diseases involving the cardiovascular, hepatic, renal, gall biliary, respiratory, hematologic/lymphatic, endocrine, immune, psychiatric, neuromuscular, or GI systems from one year prior to the first dose of study drug; or with a history (or a current condition) of GI disorders during this period, such as chronic or active upper GI diseases (e.g., esophageal disorders, gastritis, duodenitis, peptic ulcers), active GI bleeding, or history of GI surgery, as determined by the Investigator, may impact the ability of the subject to participate or potentially confound the study results.
  4. Participants who have received a radiation dose exceeding 5 mSv within the past 12 months (e.g., more than 2 cranial CT scans [approximately 2 mSv per scan], more than 3 low-dose chest CT scans [approximately 1.5 mSv per scan], more than 1 standard chest CT scan [4-7 mSv per scan], or more than 1 abdominal CT scan [8 mSv per scan]), or have received a total radiation dose over 10 mSv in the preceding 5 years, or are scheduled to undergo additional radiological examinations during the trial or within one year after the completion of the trial.
  5. AST > ULN or bilirubin > ULN.
  6. Creatinine clearance <90 mL/min during screening (calculation formula of Creatinine Clearance is detailed in Section 8.2.1.6).
  7. Participants with a history or presence of hypothyroidism.
  8. Participants with a history of drug abuse within 5 years or intake of any narcotics within 6 months before the initial administration, or who have a positive drug abuse test on admission.
  9. Participants with a history of alcohol abuse within 6 months before the initial administration, defined as an average alcohol intake > 2 units/day (1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).
  10. Participants with a history of smoking > 5 cigarettes/day within 3 months before the initial administration or unable to refrain from using any tobacco or nicotine-containing product within 48 hours prior to administration and during hospitalization.
  11. Participants who have donated or lost blood > 400 mL within 3 months before the initial administration.
  12. Participants who have received major surgery or hospitalized within 3 months before the initial administration.
  13. Participants who have received investigational drugs or participated in other clinical trials within 3 months before the initial administration.
  14. Participants who have received prescription drug within 14 days before the initial administration.
  15. Participants who have taken high-density medications such as bismuth agents and calcium agents within 7 days before the initial administration.
  16. Participants who have received over the counter (OTC) drug or herb within 7 days before the initial administration.
  17. Participants who have consumed grapefruit juice, or other food or beverage containing caffeine or xanthine within 7 days before the initial administration.
  18. Participants who have drunk alcohol within 48 hours before the initial administration or with a positive breath alcohol test (> 0 mg/100 mL).
  19. Participants cannot receive standard meals during the study.
  20. Participants who cannot tolerate venipuncture or have a history of fear of needles or hemophobia.
  21. Participants with vitamin B12 deficiency.
  22. Participants with acute minor diseases (common cold, diarrhea, etc.) during screening.
  23. For female participants, breastfeeding or positive for pregnancy test at screening, or who have unprotected sexual contact within 2 weeks before dosing, or who have intrauterine devices in their bodies.
  24. Participants who are not suitable for participating in this study due to other reasons as judged by Investigator.

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
実験的:T25-Fast
T25 administrated in fast state
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state
実験的:T25 -Fed
T25 administrated in fed state
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state
アクティブコンパレータ:mycapssa
Mycapssa administrated in fast state
Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state

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
bioavailability
時間枠:From time 0 (administration) to 24 hours post-administration
The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)
From time 0 (administration) to 24 hours post-administration
bioavailability
時間枠:From time 0 (administration) to 24 hours post-administration
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax
From time 0 (administration) to 24 hours post-administration
bioavailability
時間枠:From time 0 (administration) to 24 hours post-administration.
The ratio of geometric least square means between the T25 and MYCAPSSA® for area under the concentration-time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast) . Sampling (Fasted condition) occurs at the following timepoints: 0 (pre-dose) , 0.5 , 1.0, 1.33 , 1.67 , 2.0 , 2.33 , 2.67 , 3.0 , 3.33 , 3.67 , 4.0 , 4.5 , 5.0 , 5.5 , 6.0 , 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose.
From time 0 (administration) to 24 hours post-administration.
bioavailability
時間枠:From 0 (administration) to 24hour
The ratio of geometric least square means between the T25 and MYCAPSSA® for AUC from time zero to infinity (AUC0-inf) via dose normalization. AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)
From 0 (administration) to 24hour
bioavailability
時間枠:From time 0 (administration) to 24 hours post-administration.
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC0-tlast (sampling occurs at the following timepoints: Fasted condition: 0 (pre-dose) , 0.5 , 1.0, 1.33, 1.67, 2.0, 2.33, 2.67, 3.0, 3.33, 3.67, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose; Fed condition: 0 (pre-dose), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 , 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 , 11.0, 12.0, 14.0, 16.0, 24.0 hour post-dose;)
From time 0 (administration) to 24 hours post-administration.
bioavailability
時間枠:From time 0 (administration) to 24hour.
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC from time zero to infinity (AUC0-inf).AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)
From time 0 (administration) to 24hour.

二次結果の測定

結果測定
メジャーの説明
時間枠
PK profile (Tlag)
時間枠:From time 0 (administration) to 24 hours post-administration
the first observation with a measurable (non-zero) concentration (Tlag)
From time 0 (administration) to 24 hours post-administration
PK profile(Tmax)
時間枠:From time 0 (administration) to 24 hours post-administration
time to reach maximum plasma concentration
From time 0 (administration) to 24 hours post-administration
PK profile(t₁/₂)
時間枠:From time 0 (administration) to 24 hours post-administration
elimination half-life (t₁/₂)
From time 0 (administration) to 24 hours post-administration
PK profile(Kel)
時間枠:From time 0 (administration) to 24 hours post-administration
elimination rate constant
From time 0 (administration) to 24 hours post-administration
PK profile(CL/F)
時間枠:From time 0 (administration) to 24 hours post-administration
apparent total clearance after oral administration
From time 0 (administration) to 24 hours post-administration
PK profile(Vz/F)
時間枠:From time 0 (administration) to 24 hours post-administration
apparent volume of distribution after oral administration
From time 0 (administration) to 24 hours post-administration
PK profile(AUC_%Extrap)
時間枠:From time 0 (administration) to 24 hours post-administration
percentage of area under the concentration-time curve extrapolated beyond the last measurable concentration
From time 0 (administration) to 24 hours post-administration
the gastrointestinal transit of T25 using an abdominal X-ray
時間枠:Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose.
the abdominal X-ray
Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose.
the gastrointestinal transit of T25 using an abdominal X-ray
時間枠:Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose.
the abdominal X-ray
Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose.
Safety and tolerability - number and severity of adverse events
時間枠:From the first dose until 7 days after the last dose
Incidence and severity of AE
From the first dose until 7 days after the last dose
Safety and tolerability -Temperature (ear)
時間枠:From the first dose until 7 days after the last dose
Incidence of Adverse Events and Abnormalities as assessed by Temperature (ear)
From the first dose until 7 days after the last dose
Safety and tolerability - Blood pressure
時間枠:From the first dose until 7 days after the last dose
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
From the first dose until 7 days after the last dose
Safety and tolerability -Pulse
時間枠:From the first dose until 7 days after the last dose
Incidence of Adverse Events and Abnormalities as assessed by pulse
From the first dose until 7 days after the last dose
Safety and tolerability - Physical examination
時間枠:From the first dose until 7 days after the last dose
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
From the first dose until 7 days after the last dose
Safety and tolerability - clinical laboratory tests
時間枠:From the first dose until 7 days after the last dose
Number of abnormalities assessed based on safety bloods and urine test( hematology, blood biochemistry, coagulation function, urinalysis, thyroid function, serum vitamin B12, serum pregnancy test (only for females), etc)
From the first dose until 7 days after the last dose
Safety and tolerability - ECG
時間枠:From the first dose until 7 days after the last dose
Heart Rate, PR Interval, QRS duration,QT Interval,QTc Interval
From the first dose until 7 days after the last dose

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。

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25日

一次修了 (実際)

2026年7月22日

研究の完了 (実際)

2026年7月24日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16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15日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

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

はい

米国FDA規制機器製品の研究

いいえ

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