Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06254235
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
Participants will receive single-dose of either test or reference octreotide microsphere formulations.
Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
Participants will receive single-dose of either test or reference octreotide microsphere formulations.
Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: