A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Dulaglutide.

It had two arms (groups): 14028 injection (experimental) and dulaglutide injection (TRULICITY®) (active comparator).

The registry classes the interventions as biological.

Who Took Part

68 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily. Healthy male subjects aged 18 to 45 (including the critical value). Weight \> or = 50 kg, and 19.0 kg/m2 \< or = BMI (body mass index) \< or = 28.0 kg/m2.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: past or current history of pancreatitis (chronic or acute pancreatitis); past or current history of habitual constipation or intestinal obstruction; those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding.

How the Study Was Run

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

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

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

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

It started in 2022-05-31 with completion listed for 2022-07-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum (peak) plasma drug concentration(Cmax). Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞).

It also tracked 6 secondary outcomes, for example Area under the plasma concentration-time curve from time zero to time t (AUC0-t), Time to reach maximum plasma concentration following drug administration (Tmax), Elimination half-life (t1/2), Apparent total body clearance (CL/F), Apparent volume of distribution (Vd/F) and Elimination constants (λz).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 68 people.

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

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