Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT03199261
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2017-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: