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CompletedNCT07663318Updated Sep 16, 2026

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)

A Phase 1 interventional study of T25-Fast and Mycapssa in Acromegaly, sponsored by Triastek (Shanghai) Limited. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Triastek (Shanghai) Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acromegaly

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Keywords

  • Octreotide
03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 18 is below the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

This is the only study on the registry with Triastek (Shanghai) Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male or female aged 18 to 55 years (both inclusive).
  2. Participants with a (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 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 must agree to use adequate and have no plan for pregnancy from screening period throughout 3 months after the last dose of 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 form prior to the initiation of any study procedures.
  6. Participants with high compliance for all protocol requirements.

Exclusion criteria

Exclusion Criteria:

  1. Participants with allergic disease or allergic to products or its , or more than two kinds of medications, food, or beverage.
  2. Participants with positive for (HIV) antibody test; active infection with , 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. > or > ULN.
  6. \<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.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    T25-Fast

    T25 administrated in fast state

    Drug: T25-Fast

  • Experimental
    T25 -Fed

    T25 administrated in fed state

    Drug: T25-Fed

  • Active comparator
    mycapssa

    Mycapssa administrated in fast state

    Drug: Mycapssa

Interventions

  • DrugT25-Fast

    Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state

  • DrugMycapssa

    Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state

  • DrugT25-Fed

    Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state

06

What researchers measure

Primary outcomes

  1. bioavailability

    The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)

    Time frame: From time 0 (administration) to 24 hours post-administration

  2. bioavailability

    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.

    Time frame: From time 0 (administration) to 24 hours post-administration.

  3. bioavailability

    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)

    Time frame: From 0 (administration) to 24hour

  4. bioavailability

    The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax

    Time frame: From time 0 (administration) to 24 hours post-administration

  5. bioavailability

    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;)

    Time frame: From time 0 (administration) to 24 hours post-administration.

  6. bioavailability

    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)

    Time frame: From time 0 (administration) to 24hour.

Secondary outcomes

  1. PK profile (Tlag)

    the first observation with a measurable (non-zero) concentration (Tlag)

    Time frame: From time 0 (administration) to 24 hours post-administration

  2. PK profile(Tmax)

    time to reach maximum plasma concentration

    Time frame: From time 0 (administration) to 24 hours post-administration

  3. PK profile(t₁/₂)

    elimination half-life (t₁/₂)

    Time frame: From time 0 (administration) to 24 hours post-administration

  4. PK profile(Kel)

    elimination rate constant

    Time frame: From time 0 (administration) to 24 hours post-administration

  5. PK profile(CL/F)

    apparent total clearance after oral administration

    Time frame: From time 0 (administration) to 24 hours post-administration

  6. PK profile(Vz/F)

    apparent volume of distribution after oral administration

    Time frame: From time 0 (administration) to 24 hours post-administration

  7. PK profile(AUC_%Extrap)

    percentage of area under the concentration-time curve extrapolated beyond the last measurable concentration

    Time frame: From time 0 (administration) to 24 hours post-administration

  8. the gastrointestinal transit of T25 using an abdominal X-ray

    the abdominal X-ray

    Time frame: 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.

  9. the gastrointestinal transit of T25 using an abdominal X-ray

    the abdominal X-ray

    Time frame: 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.

  10. Safety and tolerability - number and severity of adverse events

    Incidence and severity of AE

    Time frame: From the first dose until 7 days after the last dose

  11. Safety and tolerability -Temperature (ear)

    Incidence of Adverse Events and Abnormalities as assessed by Temperature (ear)

    Time frame: From the first dose until 7 days after the last dose

  12. Safety and tolerability - Blood pressure

    Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)

    Time frame: From the first dose until 7 days after the last dose

  13. Safety and tolerability -Pulse

    Incidence of Adverse Events and Abnormalities as assessed by pulse

    Time frame: From the first dose until 7 days after the last dose

  14. Safety and tolerability - Physical examination

    Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination

    Time frame: From the first dose until 7 days after the last dose

  15. Safety and tolerability - clinical laboratory tests

    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)

    Time frame: From the first dose until 7 days after the last dose

  16. Safety and tolerability - ECG

    Heart Rate, PR Interval, QRS duration,QT Interval,QTc Interval

    Time frame: From the first dose until 7 days after the last dose

07

Study locations

1 site
  • Zibo Central Hospital
    Zibo, Shandong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2026 to primary completion in Jul 2026, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2026
First posted
Jun 23, 2026
StartActual
Jun 25, 2026
Primary completionActual
Jul 22, 2026
CompletionActual
Jul 24, 2026
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07663318
Lead sponsor
Triastek (Shanghai) Limited
Collaborators
Zibo Central Hospital
Responsible party
Sponsor
First posted
Jun 23, 2026
Start date
Jun 25, 2026
Primary completion
Jul 22, 2026
Completion
Jul 24, 2026
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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