Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308679
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-06
Brief Title:
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions
Sponsor:
Pharma Nueva
Organization:
Pharma Nueva
Study Overview
Official Title:
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Objectives
Primary
to evaluate the bioequivalence of two formulations of Empagliflozin tablets test formulation and reference innovator formulation after a single oral dose administration in healthy Thai subjects under fasting conditions
Secondary
To examine the pharmacokinetics and safety of test and reference formulations
Study Design
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions
Primary
to evaluate the bioequivalence of two formulations of Empagliflozin tablets test formulation and reference innovator formulation after a single oral dose administration in healthy Thai subjects under fasting conditions
Secondary
To examine the pharmacokinetics and safety of test and reference formulations
Study Design
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions
Detailed Description:
Subjects will be fasted at least 10 hours before dosing After that a single dose of 10-mg Empagliflozin tablets will be administered along with 240 mL of drinking water under fasting condition In each period a total of 21 blood samples approximately 6 mL each from 21 sampling time points will be collected at pre-dose 6-mL tubes and at 033 067 100 150 200 250 300 350 400 450 500 600 700 800 1000 1200 1400 2400 3600 and 4800 h post dose Blood glucose level will be measured at approximately pre-dose 033 067 100 150 200 250 300 350 400 hours post-dose in each period for subjects safety During blood sample collection one drop of blood will be used for this test
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?:
None