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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: rE-4 Injection; Drug: rE-4 Freeze-dried Powder

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100071
    • The Affiliated Hospital Military Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: Hengyan Qu, Ph.D, The Affiliated Hospital Military Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 23, 2016
• Primary Completion (Actual): January 21, 2017
• Study Completion (Actual): January 21, 2017

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: SN-YQ-2016018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO