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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)

NCT07663318 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-06-29

No results posted yet for this 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.

Conditions

Interventions

DRUG

T25-Fast

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

DRUG

Mycapssa

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

DRUG

T25-Fed

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

Sponsors & Collaborators

  • Zibo Central Hospital

    collaborator OTHER_GOV

  • Triastek (Shanghai) Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2026-07-10
Completion
2026-09-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663318 on ClinicalTrials.gov