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

NCT03199261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-26

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hengyan Qu, Ph.D · The Affiliated Hospital Military Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-23
Primary Completion
2017-01-21
Completion
2017-01-21

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199261 on ClinicalTrials.gov