Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519604
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Open Randomized Crossover Study on PK PD Biopotency and Bioavailability of Insulin Capsules in Healthy Chinese Males
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Randomized Single Dose Two-way Crossover Study on Pharmacokinetics Pharmacodynamics Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pharmacokinetics and pharmacodynamics study of 3 formulations human insulin enteric coated capsules 8mg vers human insulin injection 5IUhuman insulin enteric coated capsules 16mg vers Human Insulin Injection 5IU Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg16mg vers human insulin injection 5IU
Detailed Description:
An open randomized single dose two-way crossover study on Pharmacokinetics pharmacodynamics relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic euglycemic clamp
Study Oversight
Has Oversight DMC:
None
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?:
None