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

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ClinicalTrials.gov Identifier: NCT03199261
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: rE-4 Injection Drug: rE-4 Freeze-dried Powder Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Study Start Date : December 23, 2016
Actual Primary Completion Date : January 21, 2017
Actual Study Completion Date : January 21, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

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 Name: 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 Name: Recombinant Exendin-4 Freeze-dried Powder




Primary Outcome Measures :
  1. Bioequivalency between the 2 formulations of rE-4 [ Time Frame: 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 ]
    Area under curve



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199261


Locations
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China
The Affiliated Hospital Military Medical Sciences
Beijing, China, 100071
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Hengyan Qu, Ph.D The Affiliated Hospital Military Medical Sciences

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03199261     History of Changes
Other Study ID Numbers: SN-YQ-2016018
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists