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NOT YET RECRUITING
NCT07663318
PHASE1

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)

Sponsor: Triastek (Shanghai) Limited

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-06-26

Completion Date

2026-09-30

Last Updated

2026-06-23

Healthy Volunteers

Yes

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