Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-16 @ 10:03 AM
Study NCT ID:
NCT06161220
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects
Sponsor:
Impax Laboratories, LLC
Organization:
Study Overview
Official Title:
A Three-Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of a Supratherapeutic Dose of Carbidopa in Healthy Subjects
Status:
COMPLETED
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:
The purpose of this trial is to assess the effects of a single supratherapeutic dose of carbidopa on cardiac repolarization relative to placebo in healthy adult subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: