Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Octreotide.

It had two arms (groups): Test (experimental) and Reference (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 240 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: BMI 19-28 kg/m\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female. In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination. Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion. Fully understood and voluntarily signed the informed consent form. With high compliance.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: with allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage; positive for human immunodeficiency virus, hepatitis b, c, or syphilis test; with gastrointestinal disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2021-06-16 with completion listed for 2021-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC0-28d (time frame: Day 0-28). AUC28-56d (time frame: Day 28-56). AUC0-t (time frame: Day 0-82).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 240 people.

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.