Clinical Trial

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)

Not Yet Recruiting Phase 1
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Record status
This record was last updated June 29, 2026 (before its estimated July 10, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-17.
Trial Details
NCT Number NCT07663318
Lead Sponsor Triastek (Shanghai) Limited
Collaborators: Zibo Central Hospital
Conditions Acromegaly
Enrollment 18 participants
Start Date 2026-06-26
Primary Completion 2026-07-10 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-29