A Study of Pharmacokinetic Comparison of Two Recombinant... | NCT03199261

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

NCT03199261

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Status

Completed

Last Update Posted

Jun 26, 2017Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Type 2 Diabetes

Interventions

rE-4 Injection
rE-4 Freeze-dried Powder

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2016

Primary Completion Date

Jan 21, 2017Actual

Completion Date

Jan 21, 2017Actual

First Submitted Date

Jan 17, 2017

First Submission Date that Met QC Criteria

Jun 23, 2017

First Posted Date

Jun 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2017

Last Update Posted Date

Jun 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rE-4 Injection	Experimental	10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast.	Drug: rE-4 Injection
rE-4 Freeze-dried Powder	Active Comparator	10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast.	Drug: rE-4 Freeze-dried Powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rE-4 Injection	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hengyan Qu, Ph.D	The Affiliated Hospital Military Medical Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Hospital Military Medical Sciences		Beijing		100071	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases