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

NCT03199261 · Completed

Last updated 2026-05-28

This study compared how two versions of a diabetes medication (recombinant exendin-4) are absorbed in the body when given to healthy Chinese men.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 24 people

Who can join Ages 18–45 · male only Healthy volunteers accepted.

Timeline Started 2016-12 · est. completion 2017-01

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT03199261 ↗

Description as written by the study sponsor.

Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.

rE-4 Injection also known as Recombinant Exendin-4 Injection Drug

During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast.
rE-4 Freeze-dried Powder also known as Recombinant Exendin-4 Freeze-dried Powder Drug

During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast.

Main thing measured	Bioequivalency between the 2 formulations of rE-4
Sponsor	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03199261 ↗