A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects

What Was Tested

The trial (phase 1) is built around Exenatide.

It had two arms (groups): rE-4 Injection (experimental) and rE-4 Freeze-dried Powder (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 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: Healthy male adult volunteers of 18-45 years old, who can be inserted needle. Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2，During Screening period body weight≥50 kg. Subjects are fully informed and voluntarily consent to participate in this study.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: history or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases; history or presence neurological disorder disease; participation in a clinical drug study 30 days prior to present study.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

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

It started in 2016-12-23 with completion listed for 2017-01-21.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bioequivalency between the 2 formulations of rE-4 (time frame: before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 24 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 Exenatide compound page, all human trials.