Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 12:08 PM
Study NCT ID:
NCT04921566
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions
Sponsor:
Pharmtechnology LLC
Organization:
Study Overview
Official Title:
Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Torasemide Tab. 10mg (Pharmtechnology LLC,Belarus) 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:
False
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?: