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

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

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.

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.