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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199261
• Other study ID #: SN-YQ-2016018
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2017
• Last updated: June 23, 2017
• Start date: December 23, 2016
• Est. completion date: January 21, 2017

Study information

• Verified date: December 2016
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 21, 2017
• Est. primary completion date: January 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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