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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-23

Study Completion Date

2017-01-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rE-4 Injection

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

Group Type EXPERIMENTAL

rE-4 Injection

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

rE-4 Freeze-dried Powder

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Recombinant Exendin-4 Injection Recombinant Exendin-4 Freeze-dried Powder

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes