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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: rE-4 Freeze-dried Powder; Drug: rE-4 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03199261

SN-YQ-2016018

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

rE-4 Injection

Experimental group

Description:

10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast.

Treatment:

Drug: rE-4 Injection

rE-4 Freeze-dried Powder

Active Comparator group

Description:

10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast.

Treatment:

Drug: rE-4 Freeze-dried Powder