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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03199261

Enrollment

Registered

2017-06-26

Start date

2016-12-23

Completion date

2017-01-21

Last updated

2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

Detailed description

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.

Interventions

DRUGrE-4 Injection

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.

DRUGrE-4 Freeze-dried Powder

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalency between the 2 formulations of rE-4	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	Area under curve

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026