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

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

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: rE-4 Injection
* Drug: rE-4 Freeze-dried Powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rE-4 Injection<br>10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast. | Drug: rE-4 Injection<br>* 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.<br>* Other names: Recombinant Exendin-4 Injection;|
| Active Comparator: rE-4 Freeze-dried Powder<br>10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast. | Drug: rE-4 Freeze-dried Powder<br>* 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.<br>* Other names: Recombinant Exendin-4 Freeze-dried Powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalency between the 2 formulations of rE-4 | Area under curve | 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 |