Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921566
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2021-06-04
Brief Title:
Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions
Sponsor:
Pharmtechnology LLC
Organization:
Pharmtechnology LLC
Study Overview
Official Title:
Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Torasemide Tab 10mg Pharmtechnology LLCBelarus and Toradiur Tab 10mg MEDA Manufacturing Cologne Germany in Healthy Volunteers Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2021-06
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:
This is an open-labeled laboratory blinded randomized two period single-center crossover comparative study where each participant will be randomly assigned to the reference Toradiur 10 mg or the test Torasemide 10 mg formulation in each period of study sequences Test-Reference TR or Reference-Test RT in order to evaluate if both formulations 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?:
None