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)

What Was Tested

The trial (phase 1) is built around Octreotide.

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.

It had three arms (groups): T25-Fast (experimental), T25 -Fed (experimental) and mycapssa (active comparator).

T25 administrated in fast state.

T25 administrated in fed state.

Mycapssa administrated in fast state.

The registry classes the interventions as drug.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male or female aged 18 to 55 years (both inclusive). 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. Participants must fully understand and voluntarily sign the informed consent form prior to the initiation of any study procedures. Participants with high compliance for all protocol requirements.

The full record lists 6 inclusion and 24 exclusion criteria; among the exclusions: participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage; participants with positive for human immunodeficiency virus (hiv) antibody test; active infection with hepatitis b, c; positive treponema pallidum antibody test; AST \> ULN or bilirubin \> ULN.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

Being open-label, the Octreotide study did not mask who received what.

It started in 2026-06-25 with completion listed for 2026-07-22.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): bioavailability (time frame: From time 0 (administration) to 24 hours post-administration). bioavailability (time frame: From time 0 (administration) to 24 hours post-administration). bioavailability (time frame: From 0 (administration) to 24hour).

It also tracked 16 secondary outcomes, for example PK profile (Tlag), PK profile(Tmax), PK profile(t₁/₂), PK profile(Kel), PK profile(CL/F) and PK profile(Vz/F).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.