CompletedPhase 1

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

The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 19-26•Male•Healthy volunteers

Primary endpoint

•Bioequivalency between the 2 formulations of rE-4

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03199261

Org study IDSN-YQ-2016018

Timeline

Milestones

Study start2016-12-23

Primary completion2017-01-21actual

Study completion2017-01-21actual

Study first posted2017-06-26actual

Last update posted2017-06-26actual

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•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.

Exclusion criteria

•A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.

•History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.

•History or presence neurological disorder disease.

•Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.

•Participation in a clinical drug study 30 days prior to present study.

•FPG≥6.1mmol/L or <3.9mmol/L.

•SBP<90mmHg or >140mmHg; DBP>90mmHg.

•Use of any other drugs,vitamine and mineral substance.

•Blood donation more than 200 mL blood within 3 months prior to the study.

•Smoker (>5 cigarettes/day) or alcoholist (355 ml alcohol/day).

•History or Family history of hypoglycemia.

•History of allergy or hypersensitivity.

•Subjects planning to give birth or donate sperm during the study or within 3 months after the study.

•Other unfavorable factors diagnosed by investigators.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.